Organization of Health Care

UNIVERSIDAD POLITÉCNICA DE MADRID

ESCUELA TÉCNICA SUPERIOR DE INGENIEROS DE TELECOMUNICACIÓN

A MULTIDISCIPLINARY REFERENCE FRAMEWORK TO SUPPORT INNOVATIVE DESIGN, IMPLEMENTATION AND ASSESSMENT OF CHRONIC CARE MODELS

TESIS DOCTORAL

GIUSEPPE FICO

INGENIERO ELECTRÓNICO

Madrid, 2015

Life Supporting Technologies

Departamento de Tecnología Fotónica y Bioingeniería

E.T.S.I Telecomunicación

A MULTIDISCIPLINARY REFERENCE FRAMEWORK TO SUPPORT INNOVATIVE DESIGN, IMPLEMENTATION AND ASSESSMENT OF CHRONIC CARE MODELS

Autor:

Giuseppe Fico

Ingeniero Electrónico

Directora:

María Teresa Arredondo Waldmeyer

Doctora Ingeniera de Telecomunicación

Madrid, 2015

Tribunal nombrado por el Magnífico y Excelentísimo Sr. Rector de la Universidad Politécnica de Madrid.

Presidente: D. Javier Uceda Antolín Doctor en Ingeniería Industrial, Catedrático de Universidad, ETS de Ingenieros Industriales. Universidad Politécnica de Madrid (UPM)

Vocales: D.Julio Mayol Martínez Doctor en Medicina y Cirugía, Profesor Titular de Cirugía Facultad de Medicina. Universidad Complutense de Madrid

D. Lucio Adrian Ruiz Doctor en Ingeniería Biomedica, Secretario del Dicasterio para las Comunicaciones. Ministerio de las Comunicaciones del Vaticano

D. Alejandro Rodríguez Doctor en Ingeniería de Ascaso Telecomunicación. Prof. Ayudante doctor Universidad Nacional de Educación a Distancia (UNED)

Secretario: D. José Javier Serrano Doctor en Ingeniería de Olmedo Telecomunicación. Subdirector Centro de Tecnología Biomédica Universidad Politécnica de Madrid

Suplentes: Da Konstantina Nikita Doctora en Ingeniería Biomedica. Catedrática de Universidad National Technical University of Athens

D. Jordi Arguiló Llobet Doctor en Física. Catedrático de Universidad Autónoma de Barcelona

Realizado el acto de defensa y lectura de la tesis el día ___de___de___ en Madrid, acuerda otorgarle la califcación de:

El Presidente Los Vocales El Secretario

A Multidisciplinary reference framework to support innovative design, implementation and assessment of chronic care models Giuseppe Fico November 16, 2015

“Adesso verranno tutti da te e ti tormenteranno con l' ossessione della tecnica, del posizionamento della macchina da presa, della luce. Tu lasciali perdere. La tecnica, senza personalità, è niente. Fai il tuo film e racconta la tua storia come se fossi con gli amici al bar”

(Federico Fellini, talking to Lina Wertmüller, the first woman nominated for an Academy Award)

ABSTRACT Nowadays, for the first time in history, most people can expect to live into their sixties and beyond (United Nations, 2015). However, little evidence suggests that older people are experiencing better health than their parents, and most of the health problems of older age are linked to Chronic Diseases (WHO, 2015). The established health care systems in developed countries are well suited to the treatment of acute diseases but are mostly inadequate for dealing with CDs. Healthcare systems are challenging the burden of chronic diseases by putting more emphasis on the prevention of disease and by looking for new ways to reorient the provision of care (Kane et al., 2005). According to an evidence- based review commissioned by the British NHS Institute, few models have conceptualized effective components of care for CDs and these components have been not structured and articulated. “Consequently, there is limited evidence about the real impact of any of the existing models” (Ham, 2006).

Innovations could support to achieve better diagnosis, treatment and management for patients across the continuum of care, by supporting health professionals and empowering patients to take responsibility. However, the way they are delivered is not sufficiently efficient, effective and consumer friendly. The improvement of innovation delivery, involves the creation of multidisciplinary research teams and taskforces, rather than just working teams.

There are several actions to improve the adoption of innovations from healthcare systems that are tackling the epidemics of CDs: 1) Translate Evidence-Based Healthcare (EBH) into actionable knowledge; 2) Face the complexity of healthcare through multidisciplinary research; 3) Identify a systematic approach to support effective implementation of healthcare interventions through innovation. The framework proposed in this research work is an attempt to provide these improvements.

The following hypotheses have been drafted:

. Hypothesis 1: it is possible to define a translation process to convert a model of chronic care into a structured description of goals, requirements and key performance indicators. . Hypothesis 2: a translation process, if executed through evidence-based, multidisciplinary, holistic and business-oriented elements, can convert a model of chronic care in a descriptive framework, which defines the whole development cycle of innovative solutions for chronic disease management. . Hypothesis 3: it is possible to design a method to evaluate processes, outcomes and skill acquisition capacities, and assist multidisciplinary research teams in the creation of innovative solutions for chronic disease management. . Hypothesis 4: it is possible to assist the development of innovative solutions for chronic disease management through a reference framework and produce positive effects, measured through key performance indicators.

In order to verify the hypotheses, a methodological approach, composed of four Phases that correspond to each one of the stated hypothesis, was defined. Prior to this, a “Phase 0”, consisting in a multi-domain and multi-disciplinary background analysis of the problem (i.e.: systematic adoption of innovation to chronic care), was carried out. During phase 1, in order to verify the first hypothesis, a Knowledge Translation Process (KTP) was developed, starting from the JBI Joanna Briggs Institute (JBI) model of evidence-based healthcare was used (Pearson, 2005) and adding Four Innovation Blocks. These blocks represent an enriched description, added to the JBI model, to accelerate the transformation of evidence-healthcare through innovation; the innovation blocks are built on top of the conclusions drawn after Phase 0. The background analysis gave also indication on the materials and methods to be used for the execution of the KTP, carried out during phase 2, that translates the actual best available evidence for chronic care into action: this resulted in a descriptive Framework, which is a description of a model of chronic care (the Chronic Care Model was chosen, Wagner, 1996) in terms of goals, specified requirements and Key Performance Indicators, and articulated in the three development cycles of innovation (i.e. design, implementation and evaluation). Thanks to this result the second hypothesis was verified. During phase 3, in order to verify the third hypothesis, a mixed-method to evaluate multidisciplinary teams working on innovations for chronic care, was created, based on a mixed-method used for the evaluation of Multidisciplinary Translational Teams (Wooden, 2013). This method adds a procedural dimension to the descriptive component of the Framework, The result of this phase consisted in a draft version of the framework, ready to be tested in a real scenario. During phase 4, a single and multilevel case study, with participant-observation data collection, was carried out, in order to have a complete but at the same time multi-sectorial evaluation of the framework. The activities that the LifeStech research group carried out since 2008 to improve the management of diabetes have been selected as case study. The results achieved showed that the framework allowed to improve the research activities in different directions: the quality and quantity of the research publications that LifeStech has issued, have increased substantially; 2 project grants to improve the management of diabetes, have been assigned: the first is a grant funding applied research while the second is about accelerating innovations into the market; by using the assessment KPIs of the framework, the proof of concept validation of a prototype developed in a research project was transformed into an early stage assessment of innovative eHealth intervention for Diabetes Management, which has been recently included in the repository of innovative practice of the European Innovation Partnership on Active and Health Ageing initiative.

The verification of the 4 hypotheses lead to verify the main hypothesis of this research work: it is possible to contribute to bridge the gap between healthcare and innovation and, in turn, improve the way chronic care is delivered by healthcare systems. RESUMEN Hoy en día, por primera vez en la historia, la mayor parte de la población podrá vivir hasta los sesenta años y más (United Nations, 2015). Sin embargo, todavía existe poca evidencia que demuestre que las personas mayores, estén viviendo con mejor salud que sus padres, a la misma edad, ya que la mayoría de los problemas de salud en edades avanzadas están asociados a las enfermedades crónicas (WHO, 2015). Los sistemas sanitarios de los países desarrollados funcionan adecuadamente cuando se trata del cuidado de enfermedades agudas, pero no son lo suficientemente eficaces en la gestión de las enfermedades crónicas. Durante la última década, se han realizado esfuerzos para mejorar esta gestión, por medio de la utilización de estrategias de prevención y de reenfoque de la provisión de los servicios de atención para la salud (Kane et al. 2005). Según una revisión sistemática de modelos de cuidado de salud, comisionada por el sistema nacional de salud Británico, pocos modelos han conceptualizado cuáles son los componentes que hay que utilizar para proporcionar un cuidado crónico efectivo, y estos componentes no han sido suficientemente estructurados y articulados. Por lo tanto, no hay suficiente evidencia sobre el impacto real de cualquier modelo existente en la actualidad (Ham, 2006). Las innovaciones podrían ayudar a conseguir mejores diagnósticos, tratamientos y gestión de pacientes crónicos, así como a dar soporte a los profesionales y a los pacientes en el cuidado. Sin embargo, la forma en las que estas innovaciones se proporcionan no es lo suficientemente eficiente, efectiva y amigable para el usuario. Para mejorar esto, hace falta crear equipos de trabajo y estrategias multidisciplinares.

En conclusión, hacen falta actividades que permitan conseguir que las innovaciones sean utilizadas en los sistemas de salud que quieren mejorar la gestión del cuidado crónico, para que sea posible: 1) traducir la “atención sanitaria basada en la evidencia” en “conocimiento factible”; 2) hacer frente a la complejidad de la atención sanitaria a través de una investigación multidisciplinaria; 3) identificar una aproximación sistemática para que se establezcan intervenciones innovadoras en el cuidado de salud. El marco de referencia desarrollado en este trabajo de investigación es un intento de aportar estas mejoras. Las siguientes hipótesis han sido propuestas: Hipótesis 1: es posible definir un proceso de traducción que convierta un modelo de cuidado crónico en una descripción estructurada de objetivos, requisitos e indicadores clave de rendimiento. Hipótesis 2: el proceso de traducción, si se ejecuta a través de elementos basados en la evidencia, multidisciplinares y de orientación económica, puede convertir un modelo de cuidado crónico en un marco descriptivo, que define el ciclo de vida de soluciones innovadoras para el cuidado de enfermedades crónicas. Hipótesis 3: es posible definir un método para evaluar procesos, resultados y capacidad de desarrollar habilidades, y asistir equipos multidisciplinares en la creación de soluciones innovadoras para el cuidado crónico. Hipótesis 4: es posible dar soporte al desarrollo de soluciones innovadoras para el cuidado crónico a través de un marco de referencia y conseguir efectos positivos, medidos en

indicadores clave de rendimiento. Para verificar las hipótesis, se ha definido una aproximación metodológica compuesta de cuatro Fases, cada una asociada a una hipótesis. Antes de esto, se ha llevado a cabo una “Fase 0”, donde se han analizado los antecedentes sobre el problema (i.e. adopción sistemática de la innovación en el cuidado crónico) desde una perspectiva multi-dominio y multi- disciplinar. Durante la fase 1, se ha desarrollado un Proceso de Traducción del Conocimiento, elaborado a partir del JBI Joanna Briggs Institute (JBI) model of evidence-based healthcare (Pearson, 2005), y sobre el cual se han definido cuatro Bloques de Innovación. Estos bloques consisten en una descripción de elementos innovadores, definidos en la fase 0, que han sido añadidos a los cuatros elementos que componen el modelo JBI. El trabajo llevado a cabo en esta fase ha servido también para definir los materiales que el proceso de traducción tiene que ejecutar. La traducción que se ha llevado a cabo en la fase 2, y que traduce la mejor evidencia disponible de cuidado crónico en acción: resultado de este proceso de traducción es la parte descriptiva del marco de referencia, que consiste en una descripción de un modelo de cuidado crónico (se ha elegido el Chronic Care Model, Wagner, 1996) en términos de objetivos, especificaciones e indicadores clave de rendimiento y organizada en tres ciclos de innovación (diseño, implementación y evaluación). Este resultado ha permitido verificar la segunda hipótesis. Durante la fase 3, para demostrar la tercera hipótesis, se ha desarrollado un método-mixto de evaluación de equipos multidisciplinares que trabajan en innovaciones para el cuidado crónico. Este método se ha creado a partir del método mixto usado para la evaluación de equipo multidisciplinares translacionales (Wooden, 2013). El método creado añade una dimensión procedural al marco. El resultado de esta fase consiste, por lo tanto, en una primera versión del marco de referencia, lista para ser experimentada. En la fase 4, se ha validado el marco a través de un caso de estudio multinivel y con técnicas de observación-participante como método de recolección de datos. Como caso de estudio se han elegido las actividades de investigación que el grupo de investigación LifeStech ha desarrollado desde el 2008 para mejorar la gestión de la diabetes, actividades realizadas en un contexto internacional. Los resultados demuestran que el marco ha permitido mejorar las actividades de trabajo en distintos niveles: 1) la calidad y cantidad de las publicaciones; 2) se han conseguido dos contratos de investigación sobre diabetes: el primero es un proyecto de investigación aplicada, el segundo es un proyecto financiado para acelerar las innovaciones en el mercado; 3) a través de los indicadores claves de rendimiento propuestos en el marco, una prueba de concepto de un prototipo desarrollado en un proyecto de investigación ha sido transformada en una evaluación temprana de una intervención eHealth para el manejo de la diabetes, que ha sido recientemente incluida en Repositorio de prácticas innovadoras del Partenariado de Innovación Europeo en Envejecimiento saludable y activo.

La verificación de las 4 hipótesis ha permitido demonstrar la hipótesis principal de este trabajo de investigación: es posible contribuir a crear un puente entre la atención sanitaria y la innovación y, por lo tanto, mejorar la manera en que el cuidado crónico sea procurado en los sistemas sanitarios.

Table of contents ABSTRACT ...... XI RESUMEN ...... XIII Table of contents ...... XV List of figures ...... XVIII LIST OF TABLES ...... XXIV 1. INTRODUCTION ...... 1 Introduction to the problem and motivations of the research work ...... 5 1.1.1 The burden of chronic diseases...... 5 1.1.2 Effective and Efficient Models of Care ...... 6 1.1.3 Redesigning services enabling patient-centred care...... 9 1.1.4 Innovation in Healthcare ...... 11 1.1.5 Multidisciplinary teams to translate evidence-based healthcare ...... 12 1.1.6 Motivations and structure of the research work ...... 14 Multi-domain and multi-disciplinary background analysis ...... 16 1.2.1 Existing initiatives in tackling chronic diseases ...... 16 1.2.2 Existing effective and affordable models of chronic care ...... 23 1.2.3 R&D&I: the role of Chronic Care in the Europe 2020 initiative, the Work Programme, the EIP on AHA and the EIT-Health ...... 31 1.2.4 The role of eHealth in Health and Social Care ...... 39 1.2.5 The role of engineers in Health and Social Care ...... 45 1.2.6 Conclusions ...... 50 2. RESEARCH HYPOTHESES AND OBJECTIVES ...... 53 3. MATERIALS AND METHODS ...... 59 Introduction to the methodological approach of the research ...... 63 3.1.1 Phase 1 ...... 64 3.1.2 Phase 2 ...... 65 3.1.3 Phase 3 ...... 65 3.1.4 Phase 4 ...... 66 Materials and Methods used for each Phase ...... 67 3.2.1 “Phase 0”: background Analysis ...... 70 3.2.2 Phase 1: definition of the Knowledge Translation Process...... 71 3.2.3 Phase 2: creation of the Descriptive Component of the Framework. ... 71

3.2.4 Phase 3: creation of the procedure to evaluate multidisciplinary teams innovating in healthcare...... 99 3.2.5 Phase 4. Materials used to validate the Framework...... 102 4. RESULTS ...... 107 Introduction ...... 111 Result 1: a Knowledge Translation Process to put Evidence-based Chronic Care into action through innovation...... 112 Result 2: towards the descriptive component of the framework ...... 114 4.3.1 Block 1. The CCM processed through the ARCHO Instrument ...... 117 4.3.2 Block 2. CCM components transformed in CMaps and User Expressions 117 4.3.3 Block 3. Restructuring Knowledge ...... 121 4.3.4 Block 4. Assessment ...... 122 Result 2: the Descriptive Component of the Framework ...... 123 4.4.1 Design Cycle ...... 123 4.4.2 Implementation Cycle ...... 134 4.4.3 Evaluation Cycle ...... 152 4.4.4 Framework Consolidation...... 157 Result 3: a mixed-method approach to evaluate multidisciplinary teams innovating for improving CDs ...... 159 Developed with Stakeholders ...... 161 Result 4: validation of the framework ...... 162 4.6.1 Case Study design ...... 163 4.6.2 STAGE 1: project description and identification of phases...... 164 4.6.3 STAGE 2: framework configuration...... 167 4.6.4 STAGE 3: supporting the design cycle...... 168 4.6.5 STAGE 4: supporting the implementation cycle...... 175 4.6.6 STAGE 5: supporting the evaluation cycle...... 191 4.6.7 STAGE 6: Reporting on the results...... 237 4.6.8 Case study Conclusion: Framework Delivery...... 248 5. CONCLUSIONS...... 259 Conclusions ...... 263 Discussion of the Hypotheses ...... 264 Original Contributions ...... 268 Future Work ...... 270

REFERENCES ...... 271 PUBLICATIONS RELATED WITH THE RESEARCH WORK ...... 281 ANNEXES ...... 285 ANNEX 1 – The ARCHO Instrument ...... 289 ANNEX 2 – The CCM-ARCHO Concept Maps...... 299 ANNEX 3 – Behaviour, values and attributes specifications ...... 327 ANNEX 4 – Questionnaires used to discuss the ranking of the Hierarchy of Needs ... 331 ANNEX 5 – Questionnaires for the assessment of the design and implementation phases from the Expert Panel of the Case Study ...... 343

List of figures Figure 1 . OECD Health Data. (Adapted from (OECD, 2011)...... 7 Figure 2 - Changes to be adopted by HC systems in the Short, Medium and Long Terms...... 8 Figure 3 – Changes to be adopted by HC systems in the Short Term...... 8 Figure 4 – Changes to be adopted by HC systems in the MediumTerm...... 8 Figure 5 - Changes to be adopted by HC systems in the Long Term...... 9 Figure 6 - Representation of stages (Titles of the boxes) and actions (Text inside the boxes) that compose the “continuous health process”...... 9 Figure 7- Aligned management processes as integrators (adapted from Bengoa, 2012)...... 21 Figure 8 - "Words cloud" for Healthcare Systems and Chronic Care. The cloud has been generated from the most recurrent words of section 1.2.1...... 23 Figure 9 – “Words Cloud” for "Models of Chronic Care". The cloud has been generated from the most recurrent words of section 1.2.2...... 27 Figure 10 – “Words Cloud” for CCM and Innovation. The cloud has been generated from the most recurrent words of section 1.2.2.1...... 30 Figure 11 - Structure of the Innovation Union within the Europe 2020 agenda (adapted from Universidad Politécnica de Madrid, 2013)...... 31 Figure 12 – “Words cloud” for the Horizon 2020. The cloud has been generated from the most recurrent words of section 1.2.3...... 33 Figure 13 - Overview of the EIPonAHA Action Groups and number of Commitments (adapted from Abadie et al., 2014)...... 35 Figure 14 - Stakeholders and Countries of the EIP on AHA (adapted from Boehler and Abadie et al., 2014)...... 36 Figure 15 – “Words Cloud” for EIP on AHA. The cloud has been generated from the most recurrent words of section 1.2.3.2...... 36 Figure 16 - The 3 Strategic Challenges, Business Objectives (in green) and Scenarios (in blue) of the EIT-Health (adapted from https://eithealth.eu/)...... 37 Figure 17 – “Words Cloud” for EIT Health. The cloud has been generated from the most recurrent words of section 1.2.3.3...... 38 Figure 18 - Basic Categories for eHealth challenges (adapted from (Moen et al., 2012)...... 41 Figure 19 – “Words Cloud” for eHealth. The cloud has been generated from the most recurrent words of section 1.2.4...... 44 Figure 20 – “Words Cloud” for Biomedical Engineers. The cloud has been generated from the most recurrent words of section 1.2.5...... 49 Figure 21 – “Words Cloud” of the conclusions of the background analysis. The cloud has been generated from the most recurrent words of section 1.2.6...... 51 Figure 22 – Representation of the methodological approach of the research work. .... 63 Figure 23 - Representation of the Joanna Briggs Institute Model of evidence-based healthcare...... 64 Figure 24 - the Innovation Blocks added to the JBI model of evidence-based healthcare...... 65 Figure 25 - Materials and Methods selected to execute the KTP...... 65

Figure 26 - Representation of the objectives of the CCM: 1) Activated Patient; 2) Prepared Practice Team; 3) Productive Interactions (adapted from the image developed by The MacColl Institute, © ACP-ASIM Journals and Books, reprinted with permission from ACP-ASIM Journals and Books)...... 72 Figure 27. The Chronic Care Model (adapted from the image developed by The MacColl Institute, © ACP-ASIM Journals and Books, reprinted with permission from ACP-ASIM Journals and Books)...... 75 Figure 28 – The 3 principles that inspired the development of the ARCHO instrument: evidence based, systemic approach, continuous improvement and innovation (adapted from (Nuño-Solinís, 2013a, 2013b)...... 77 Figure 29 – Structure of the ARCHO instrument. For each one of the six ‘Elements’ of the Chronic Care Model, each dimension is organized in ‘Components’ and ‘Interventions’. (adapted from Nuño-Solinís, 2013a and 2013b)...... 78 Figure 30 - A concept map showing the key features of concept maps. Concept maps tend to be read progressing from the top downward (source: http://cmap.ihmc.us/docs/theory-of-concept-maps)...... 82 Figure 31 – Representation of the phases of CeHRes Roadmap (adapted from: http://www.ehealthresearchcenter.org/wiki/)...... 85 Figure 32 - The FBM factors needed for a behaviour to occur (source: the FBM, by Dr. BJ Fogg, Stanford University)...... 92 Figure 33 – the Fogg Behaviour Grid (source: The Behaviour Grid, by Dr. BJ Fogg, Stanford University)...... 92 Figure 34 - Elements for selection and prioritisation of policies/interventions. (Adapted from De Maeseneer, 2015)...... 97 Figure 35 – KTP to transform a model of care into a framework to assist multidisciplinary research teams in design, implementation and evaluation innovative solutions...... 113 Figure 36 - KTP+Innovation Block+"Best Available Materials and Methods" ...... 115 Figure 37 - Building the Framework: flow diagram showing the translation process and, for each block, the methods and the outputs generated ...... 116 Figure 38 – Example of Concept Map describing the first component (leadership commitment) of the first dimension (ORGANISATION OF THE HEALTH SYSTEM) of the Chronic Care Model. It is characterized by 4 actions (or behaviours) and 1 definition (leaders)...... 118 Figure 39 – Example of Concept Map describing the second component (Strategic framework) of the first dimension (ORGANISATION OF THE HEALTH SYSTEM) of the Chronic Care Model. It is characterized by 1 action, 1 concept (or condition, accompanied with a descriptive example) and 1 predicate...... 119 Figure 40 – the Strategic Framework component categorized in actions (red), concepts (blue) and predicates (green)...... 120 Figure 41 - Hierarchic Categorization of the PATIENT ACTIVATION "HC Problem". 124 Figure 42 - - Hierarchic Categorization of the PROACTIVE AND PREPARED CARE TEAM “HC Problem”...... 125 Figure 43 - Technology mapping for PATIENT ACTIVATION...... 126 Figure 44 - Technology mapping for a PROACTIVE AND PREPARED CARE TEAM. .. 127 Figure 45 - Innovation Assessment Flow...... 152

Figure 46 - Technical Structure of the METABO Project. Four Technical Subprojects (in green) organized in five, three, three and two WPs respectively, and four WPs of horizontal - management, dissemination, socio-organizational aspects, marketing and business – activities (source [METABO project archives, meeting with the coordinator, 2009-06-19] )...... 165 Figure 47 - Milestones reached during the Design Phase (extracted from METABO PMR 1, 2009)...... 169 Figure 48 - Overview of How the Expert Panel rated Patient Activation HC Improvements according to the Scientific, Healthcare and Business dimensions. .... 171 Figure 49 - Overview of How the Expert Panel rated Patient Activation HC Improvements according to the UI-Design, SW-Design and Development dimensions...... 171 Figure 50 - Overview of How the Expert Panel rated Care Team HC Improvements (Scientific, Healthcare and Business dimensions)...... 172 Figure 51 - Overview of How the Expert Panel rated Care Team HC Improvements (UI, SW and Implementation dimensions)...... 172 Figure 52 - Milestones Reached during the Implementation Phase...... 176 Figure 53 - Milestones of the 3rd Period...... 177 Figure 54 – Behaviours of Leaders: Did the Coordination Team develop a vision of Chronic (i.e.: Diabetes) Care? ...... 179 Figure 55 - Behaviours of Leaders: Did the Coordination Team allocated resources to drive transformation of Diabetes Care? ...... 180 Figure 56 - Behaviours of Leaders: Did senior clinical leaders promoted leadership of HC members? ...... 181 Figure 57 Behaviours of HC Teams: was innovation promoted and shared among HC members? ...... 182 Figure 58 - Behaviours of HC members: were formal and informal relationships encouraged? ...... 183 Figure 59 - Behaviours of HC members: were relationships with Community Stakeholders established? ...... 184 Figure 60 - Was participation of patients and caregivers encouraged? ...... 185 Figure 61 - Value Specifications of the Strategic Framework component of Dimension 1 of the CCM, rated by the Scientific and Business Managers...... 186 Figure 62 – Value Specifications of the Population Approach component of Dimension 1 of the CCM, rated by the Healthcare, Business and Scientific Managers...... 186 Figure 63 - Value Specifications of the Information system component of Dimension 1 of the CCM, rated by the Scientific, Business and Healthcare managers...... 186 Figure 64 - Value Specifications of the Funding Scheme component of Dimension 1 of the CCM, rated by the Scientific and Business Managers...... 187 Figure 65 - Value Specifications of the Social and HC Policies component of Dimension 1 of the CCM, rated by the Scientific, Business and Healthcare managers...... 187 Figure 66 - Value Specifications of the Community Strategies in Health Plans component of Dimension 2 of the CCM, rated by the Scientific, Business and Healthcare managers...... 188

Figure 67 - Value Specifications of the Alliances with Community Stakeholders component of Dimension 2 of the CCM, rated by the Scientific, Business and Healthcare managers...... 188 Figure 68 - Value Specifications of the HC dimensions (3, 4 and 5) of the CCM rated by the Healthcare Experts...... 189 Figure 69 - System Specifications rated by the Implementation Team...... 190 Figure 70 - Milestones Reached during the Implementation Phase...... 192 Figure 71 - Innovation Assessment Flow...... 194 Figure 72 - Stratification of patients with TYPE 2 DIABETES MELLITUS (from METABO D4.2, 2010)...... 199 Figure 73 - Estimated Impact of the Intervention (from METABO D4.2, 2012)...... 199 Figure 74 - Process description: preparation and installation (METABO D7.4, 2012)...... 203 Figure 75 - Process description: platform set-up (METABO D7.4, 2012)...... 203 Figure 76 - Process description: initial steps (METABO D7.4, 2012)...... 203 Figure 77 - Phases of the METABO intervention (from METABO D4.2, 2012)...... 206 Figure 78 - PC ownership among subjects...... 211 Figure 79 - mobile ownership among subjects...... 211 Figure 80 - Smartphone ownership among subjects...... 211 Figure 81 - ICT experience among patients: T1DM (blue column), and T2DM (red column). Standard deviation is reported...... 212 Figure 82 - Computer Anxiety for Ana (T1DM) and George (T2DM). Standard deviation is represented too...... 212 Figure 83 - Compliance to the prescribed usage of the System. Standard Deviation is also represented...... 213 Figure 84 - Compliance to the prescriptions. Standard Deviation is also represented...... 213 Figure 85 - Evolution of the Adherence and System Usage from the first to the last week. Specified for modules and total, for T1DM subjects...... 214 Figure 86 - Evolution of the Adherence and System Usage from the first to the last week. Specified for modules and total, for T2DM subjects...... 214 Figure 87 - Sessions that T1DM subject has dedicated per each week of the pilot. Standard Deviation is also represented...... 215 Figure 88 - Overview of the module usage through data sent, Ana Case. Standard Deviation is also represented...... 215 Figure 89 Overview of Module Usage through data sent, George Case. Standard Deviation is also represented...... 216 Figure 90 Module interactions per week, George Case. Standard Deviation is also represented...... 216 Figure 91 Control Panel Interactions per module...... 217 Figure 92 Control Panel Interactions per patient...... 217 Figure 93 Perceived Usefulness of the METABO solutions. Standard Deviation is also represented...... 218 Figure 94 Perceived Usefulness from Doctors. Standard Deviation is also represented...... 218

Figure 95 User Experience measured through Attrakdiff: Ana case. Standard Deviation is also represented...... 219 Figure 96 User Experience measured through Attrakdiff: George case. Standard Deviation is also represented...... 219 Figure 97 User Experience measured through Attrakdiff: Patient Panel case (patient’s viewpoint). Standard Deviation is also represented...... 220 Figure 98 User Experience measured through Attrakdiff: Patient Panel case (Doctors' viewpoint). Standard Deviation is also represented...... 220 Figure 99 User Experience measured through Attrakdiff: Control Panel case. Standard Deviation is also represented...... 221 Figure 100 Quality of Life assessment, before and after the study, between METABO and Control Group. Standard Deviation is also represented...... 224 Figure 101 Motivation assessment between METABO and CG. Standard Deviation is also represented...... 224 Figure 102 Actual Quality of Life assessment...... 225 Figure 103 Knowledge gained during the study. Standard Deviation is also represented...... 225 Figure 104 - Perceived importance of the learning topics. Standard Deviation is also represented. (Topic 1: Diabetes Management in general; 2: Hypo/Hyperglycaemia; 3: Complications/comorbidities; 4: BG monitoring/Insulin intakes; 5: Diet; 6: Physical Activity; 7: Pregnancy; 8: Travels; 9: Total)...... 225 Figure 105 - Incremental costs (age and gender specific). Source: MAFEIP tool...... 230 Figure 106 - Incremental effects (age and gender specific). Source: MAFEIP tool. .... 230 Figure 107 - Cost-effectiveness. Source: MAFEIP tool...... 231 Figure 108 – Population flow through model states. Source: MAFEIP tool...... 231 Figure 109 – Sensitivity analysis, the incidence is between 2.12 and 2.32. Source: MAFEIP tool...... 232 Figure 110 - Sensitivity analysis: range of costs, instead of exact numbers were hypothesized. Source: MAFEIP tool...... 232 Figure 111 - Sensitivity analysis for the Incidence Parameter in the intervention case. Source: MAFEIP tool ...... 232 Figure 112 – Sensitivity analysis for the Healthcare Costs of stable T2DM in the baseline case. Source: MAFEIP tool ...... 233 Figure 113 - Sensitivity analysis for the Healthcare Costs of T2DM Complications in the baseline case. Source: MAFEIP tool ...... 233 Figure 114- Sensitivity analysis for the Healthcare Costs of stable T2DM in the intervention case. Source: MAFEIP tool ...... 233 Figure 115 – Sensitivity analysis for the Healthcare Costs of T2DM Complications in the intervention case. Source: MAFEIP tool ...... 234 Figure 116 – “Tornado” diagram, showing the effect on incremental costs that the different parameters have. Source: MAFEIP tool ...... 234 Figure 117 - Parameter impact on incremental effects (incidence). Source: MAFEIP tool ...... 234 Figure 118 - Representation of the Main Hypothesis and Main Objective of the Research Work ...... 267 Figure 119 - Concept map for the component 1.1 of the Chronic Care Model ...... 300

Figure 120 - Concept map for the component 1.2 of the Chronic Care Model ...... 301 Figure 121 - Concept map for the component 1.3 of the Chronic Care Model ...... 302 Figure 122 - Concept map for the component 1.4 of the Chronic Care Model ...... 303 Figure 123 - Concept map for the component 1.5 of the Chronic Care Model ...... 304 Figure 124 - Concept map for the component 1.6 of the Chronic Care Model ...... 305 Figure 125 - Concept map for the component 2.1 of the Chronic Care Model ...... 306 Figure 126 - Concept map for the component 2.2 of the Chronic Care Model ...... 307 Figure 127 - Concept map for the component 2.3 of the Chronic Care Model ...... 308 Figure 128 - Concept map for the component 3.1 of the Chronic Care Model ...... 309 Figure 129 - Concept map for the component 3.2 of the Chronic Care Model ...... 310 Figure 130 - Concept map for the component 3.3 of the Chronic Care Model ...... 311 Figure 131 - Concept map for the component 3.4 of the Chronic Care Model ...... 312 Figure 132 - Concept map for the component 3.5 of the Chronic Care Model ...... 313 Figure 133 - Concept map for the component 3.6 of the Chronic Care Model ...... 314 Figure 134 - Concept map for the component 3.7 of the Chronic Care Model ...... 315 Figure 135 - Concept map for the component 4.1 of the Chronic Care Model ...... 316 Figure 136 - Concept map for the component 4.2 of the Chronic Care Model ...... 317 Figure 137 - Concept map for the component 4.3 of the Chronic Care Model ...... 318 Figure 138 - Concept map for the component 4.4 of the Chronic Care Model ...... 319 Figure 139 - Concept map for the component 4.5 of the Chronic Care Model ...... 320 Figure 140 - Concept map for the component 5.1 of the Chronic Care Model ...... 321 Figure 141 - Concept map for the component 5.2 of the Chronic Care Model ...... 322 Figure 142 - Concept map for the component 5.3 of the Chronic Care Model ...... 323 Figure 143 - Concept map for the component 6.1 of the Chronic Care Model ...... 324 Figure 144 - Concept map for the component 6.2 of the Chronic Care Model ...... 325 Figure 145 - Concept map for the component 6.3 of the Chronic Care Model ...... 326 Figure 146 Hierarchy of Needs for Citizen/Patient Activation ...... 334 Figure 147 Hierarchy of Needs for Establishing a Proactive and Prepared Care Team ...... 340 Figure 148 - Hierarchy of Needs for Patient Activation ...... 345 Figure 149 Hierarchy of Needs for Establishing a Proactive and Prepared Care Team ...... 345

LIST OF TABLES Table 1 - Summary of the main conclusions resulting from the multi-domain and multi-disciplinary analysis of existing solutions on tackling CDs ...... 50 Table 2 – Components of the CCM Dimension 1, as defined by the ARCHO instrument...... 79 Table 3 - Components of the CCM Dimension 2, as defined by the ARCHO instrument...... 79 Table 4 - Components of the CCM Dimension 3, as defined by the ARCHO instrument...... 79 Table 5 - Components of the CCM Dimension 4, as defined by the ARCHO instrument...... 80 Table 6 - Components of the CCM Dimension 5, as defined by the ARCHO instrument...... 80 Table 7 - Components of the CCM Dimension 6, as defined by the ARCHO instrument...... 80 Table 8 - Definition of the problem domain concept, by mapping ASPECS meta-model and UML constructs (extracted from http://www.aspecs.org/Home)...... 84 Table 9 - Overview of the research questions, tasks and methods suggested in the phases of the CeHReS roadmaps ( extracted from the CeHRes wiki.) ...... 86 Table 10 – Needs for PATIENT ACTIVATION ranked in the case of Chronic Patients...... 128 Table 11 - Needs for PROACTIVE AND PREPARED CARE TEAM ranked in the case of Chronic Patients ...... 129 Table 12 – Procedure adopted for the iterative Development of Multidisciplinary Specifications...... 135 Table 13 - Translation Table for the CCM Dimension 1...... 136 Table 14 - Translation Table for the CCM Dimension 2...... 139 Table 15 - Translation Table for the CCM Dimension 3...... 140 Table 16 - Translation Table for the CCM Dimension 4...... 145 Table 17 - Translation Table for the CCM Dimension 5...... 148 Table 18 - Translation Table for the CCM Dimension 6...... 150 Table 19 - Checklist activities to be assessed before implementing an innovation (source: extracted from the ScalingUpPaper)...... 153 Table 20 - KPIs to be measured by the project management team, in order to assess the uptake of the innovative intervention (source: the CeHRes Roadmap list of Uptake Indicators)...... 154 Table 21 KPIs to be measured by the project management team, in order to assess the impact on healthcare delivery (source: the CeHRes Roadmap list of Impact Indicators)...... 155 Table 22 KPIs to be measured by the project management team, in order to assess the impact on patient health&wellbeing...... 155 Table 23 KPIs to be measured by the project management team, in order to assess the impact on cost-effectiveness...... 156 Table 24 - Feedback gathered from the 1st round of individual discussions...... 157 Table 25 - Feedback gathered from the focus group...... 158

Table 26 - Evaluation factors used to evaluate the Case Study (modified from Multidisciplinary Translational Teams)...... 160 Table 27 – Excerpt from the Questionnaire used to evaluate the design phase of the innovation against the CCM HC improvements...... 161 Table 28 – Excerpt from the Questionnaire used to evaluate the implementation phase of the innovation against the CCM Interventions (in this case, Values, Attributes and System Specifications of the component 1.2 – Strategic Framework)...... 161 Table 29 - Design of the Case Study...... 163 Table 30 - Table view of Patient ACTIVATION HC improvements...... 173 Table 31 - Table View of Care Team HC Improvements...... 174 Table 32: Data collected in the study...... 208 Table 33: Baseline characteristics of the population by gender...... 210 Table 34: Total Patient’s disposition ...... 210 Table 35: Average number of messages exchanged...... 223 Table 36 - Current Care Setting ...... 228 Table 37 - Intervention Setting...... 228 Table 38 - Ability Factors Table ...... 327 Table 39 - Motivation factors...... 328 Table 40 - Ability factors for the members of the HC team ...... 329 Table 41 - Motivation factors of the HC team ...... 329 Table 42 - ability factors of the patients and informal caregivers ...... 330 Table 43 - Motivation factors for patients and informal caregivers ...... 330 Table 44 - Evaluation of Behaviours ...... 367 Table 45 - Evaluation of Behaviours of the HC team ...... 368 Table 46 - Evaluation of the patients' behaviour ...... 369 Table 47 - Implementation of Healthcare Systems related Dimensions (1 and 2) ...... 370 Table 48 - Implementation of Healthcare Systems related Dimensions (3, 4 and 5), as rated by the Healthcare Manager ...... 371 Table 49 - Implementation of System Specifications (Dimensions 3, 4, 5 and 6), rated by the Implementation Team (Definition, Design, Development) ...... 372

1. INTRODUCTION

“If I have seen further it is by standing on the shoulders of Giants” (Sir Isaac Newton).

There is little evidence to suggest that older people today are experiencing acceptable level of health and quality of life. Most of the health problems of older age are linked to Chronic Diseases. A paradigm shift in the provision of healthcare is required to solve this problem. Despite the continuous emerging of medical innovations, the way they are delivered is still not efficient, effective and consumer friendly enough. New approaches, new ways of collaboration among multidisciplinary research teams and taskforces, are needed. Chapter 1 introduces the problem, the motivation and scope of the research work. Then, a multi-disciplinary and multi-domain analysis further elaborates on the problem, and the main conclusions are drawn.

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Introduction to the problem and motivations of the research work 1.1.1 The burden of chronic diseases.

Nowadays, for the first time in history, most people can expect to live into their sixties and beyond. Between 2000 and 2050, the proportion of the world’s population over 60 years will double from 11% to 22%. Europe will have about 34% of its population over 60 (United Nations, 2015).

This is a great triumph and reflects the success of dealing with fatal childhood diseases, and mortality in older ages (WHO and UNICEF, 2012; Gakidou et al., 2010; Perstonl, 2007).

Longer lives are an incredibly valuable resources. Yet, the extent of the opportunities that arise from increasing longevity will be heavily dependent on the health of these older populations.

If these added years are dominated by rapid declines in physical and mental capacity without support, the implications for older people and for society are further more negative.

BOX 1: the burden of chronic diseases

“There is little evidence to suggest that older people today are experiencing better health than their parents”,

“Most of the health problems of older age are linked to Chronic Diseases (CD)”

(WHO Global Health Observatory, 2015).

There are three “broad transitions” in global health: 1. demographic changes, 2. changes in causes of death, 3. changes in causes of disability.

All these transitions result in: . a “shift toward a larger fraction of the burden of” CDs . an increased proportion of the burden of disease is due to disability, with respect to premature death . an increased proportion of CDs as major cause of disability

(Global Burden of Disease, World Bank and WHO, 2013)

Responding to the burden of chronic disease presents challenges for all health systems. As population ages and advances in health care allow those with once

INTRODUCTION fatal conditions to survive, the prevalence of chronic conditions is rising in many countries (WHO Regional Office Europe, 2008).

Socioeconomic, condition-related, therapy and patient-related factors influence considerably the management of CD, and a multidimensional perspective, considering the interconnection between these different types of factors, is required.

The established health care systems in developed countries are well suited to the treatment of acute diseases but are mostly inadequate for dealing with CDs.

The treatment of CDs is a rather long-term management program that aims at first stabilizing the patient’s health condition and, subsequently, at preventing long-term complications.

A key task is the adequate coordination and involvement of the necessary professional figures and the establishment of new practice guidance.

From the patient perspective, such a long-term treatment requires an everyday commitment to lifestyle changes, frequent health status monitoring, and continuous compliance to prescriptions and treatments.

An effective management of chronic diseases would only be possible with very frequent interactions between the patient and the health care provider. This model might be effective but not efficient, as it is not economically sustainable in the long run (Murray et al., 2012).

1.1.2 Effective and Efficient Models of Care

Healthcare systems are challenging the burden of chronic diseases by putting more emphasis on the prevention of disease and by looking for new ways to reorient the provision of care not only to support people with acute medical conditions, but also those with chronic illnesses.

A paradigm shift in the provision of healthcare is required to meet these needs (Kane et al., 2005).

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BOX 2: Effective and Efficient Models of Care

The “Review of UK and International frameworks for improving care for people with long term conditions”, is an evidence-based review commissioned by the British NHS Institute, in 2006.

The review, conducted to help “understanding of current international, national, and local thinking about the different approaches in use” aimed to “develop high-impact approaches, based on best evidence of ‘what works’ ”.

The review suggests that there is a great need of testing different approaches, as only few models have conceptualized effective components of care for CDs and these components have been not structured, and have not been well and formally articulated.

“Consequently, there is limited evidence about the real impact of any of the existing models” (Ham, 2006).

Therefore, models of chronic care, are clearly in need of evolution and quality improvement to tackle challenges posed by the increased demand on medical care.

In Figure 1, the growth of health expenditures of some developed countries in the 1980-90, 1990-2000 and 2000-2008 is presented (OECD, 2011), showing an unsustainable trend and a need for change.

Figure 1 . OECD Health Data. (Adapted from (OECD, 2011)1.

1 Notes: Data from Australia and Japan are 2007 data. Figures for Belgium, Canada, Netherlands, Norway and Switzerland, are OECD estimates. Break in Series AUS (1998); AUSTRIA(1990); BEL(2003, 2005); CAN(1995); FRA(1995); GER(1992); JAP(1995); NET(1998, 2003); NOR(1999); SPA(1999, 2003); SWE(1993, 2001);

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Changes have been applied since the end of the first decade of 2000 by National Health Systems (NHS) in the short, medium and long term (Figure 2).

Figure 2 - Changes to be adopted by HC systems in the Short, Medium and Long Terms.

The short term is characterized by expenditure restraints in terms of personnel, activity and services portfolio reductions, as well as new purchasing systems (Figure 3).

Figure 3 – Changes to be adopted by HC systems in the Short Term.

The medium term is characterized by efficiency-driven changes: improvements in the process, rational distribution of resources, capacity-activity balances and the emergence of efficiency innovations (Figure 4).

Figure 4 – Changes to be adopted by HC systems in the MediumTerm.

In the long term scenario, the strategic change will be to include more public/private integrations, have more focus on anticipation and prevention of

SWI(1995); UK (1997). Starting in 1993 Belgium used a different methodology. Numbers are PPP adjusted. Germany is not reported because of reunification and Italy has missing data.

INTRODUCTION

disease uptake and complications, , and try to promote a more healthy culture in society through education and awareness, putting the patient at the centre of the health care system (Figure 5).

Figure 5 - Changes to be adopted by HC systems in the Long Term.

BOX 3: Innovation to support the continuum of care.

Health is a continuous process, not just an outcome: patients must be followed throughout the whole care process and their role, together with the amount and type of resources and services that the healthcare system should deliver in each stage, must be clearly identified (Figure 6).

Figure 6 - Representation of stages (Titles of the boxes) and actions (Text inside the boxes) that compose the “continuous health process”.

In this process, innovations could support to achieve better diagnosis, treatment and management for patients across the continuum of care, by supporting health professionals and empowering patients to take responsibility.

1.1.3 Redesigning services enabling patient- centred care.

Even though a big variety of CDs exists, they all share multiple and complex causes. Some of them are: their degenerative nature, tendency to appear at a later stage of life, negative impact on the quality of life, the requirement for long term assistance and care, and the characteristics that their complications can be prevented or delayed if proper measures are taken.

Complexity increases when patients suffer of Multiple (≥2) Chronic Conditions (MCC): in this case, even if standards of care and successful chronic disease

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management models were applied, desired outcomes may not be reached for multiple reasons (Wolff et al. 2002).

The ability, from the patients, to understand the cause-effect relation of the combination of lifestyle choices and therapeutic treatments that need to be followed becomes crucial, not only for the management of their conditions and adherence to prescriptions, but also for their autonomy and quality of life.

Designing services that support patients in the self-management of long-term therapies seems a particularly promising strategy, but several authors identified the quality of relationship between the patient and the healthcare provider as one of the main determinants of successful self-management (Dunbar-Jakob et al. 2000, Martin et al. 2005,).

BOX 4: towards patient-centred care.

The extent to which a process of genuinely shared decision making is in place between the patient and the healthcare team, is a key factor in determining the success of care plans in achieving positive health outcomes.

Shared decision making implies taking a patient-centred approach, but also depends on: . an activated patient, who has the confidence and skills to engage in such a process of shared decision making and take a proactive role in the management of his/her own health, and . an informed and organized professional team of careers supporting the treating physician in follow-up and therapeutic decisions.

(Wagner et al. 2001).

To achieve this, a lengthy process based on a proactive attitude from both patients and care providers is needed, building on the availability of flexible means of information and communication.

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1.1.4 Innovation in Healthcare

Despite the exponential and astonishing advances in medical treatments, the way they are delivered is not sufficiently efficient, effective and consumer friendly. Innovative solutions in several aspects of healthcare are needed.

BOX 5: Innovation in Healthcare

In the editorial of the Harvard Business Review “Why innovation in health care is so hard”, Regina Herzlinger stated that “there are three types of innovations”: 1. change the way healthcare is delivered to end-users, 2. use technology2 to develop new products and treatments and 3. generate new business models, involving horizontal and vertical integration activities. and “six forces that can drive or kill innovation”: 1. Players: there are many stakeholders with competent interests. Innovators need to acknowledge this reality and establish alliances with them, to avoid seeing their efforts being wasted. 2. Funding: it is difficult to find investors and traditional sources of capital investments are still not familiar with the health care business. New methods to better inform the decision makers are needed. 3. Policy: regulation can prevent but sometime also aid innovation. It is important to understand and control the network of regulations affecting innovation. 4. Technology: the enormous dynamicity and consequent intrinsic obsolescence of medical technology demands clear strategies on how and where to deploy a potential successful solution. 5. Customers: recognizing the consumer’s growing sense of empowerment will help to enhance the adoption of an innovation. 6. Accountability: the demand from consumers and payers that innovative health care products be safe, effective, but also cost- effective

“Analysing these forces is helpful in understanding how to introduce innovations to improve HC systems. In Europe, where the government is a primary payer: . Customer-focused innovation is almost impossible. . Technology-based innovation is restricted and regulated by Health Technology Assessment agencies, since cost expenditure maintenance drives the way health care investments and service adoptions are implemented. . This causes the absence of a large venture capital community. However, the centralized nature of European HC systems offers the potential for innovation in treatment for chronic diseases, especially in integration of services

“Why innovation in health care is so hard”, of the Harvard Business Review (Herzlinger, 2006).

2 According to the WHO, “Health technology refers to the application of organized knowledge and skills in the form of devices, medicines, vaccines, procedures and systems developed to solve a health problem and improve quality of lives”.

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1.1.5 Multidisciplinary teams to translate evidence-based healthcare

The improvement of innovation delivery, involves the creation of multidisciplinary research teams and taskforces, rather than just working teams (Fiore, 2008).

There are several initiatives that are trying to find solutions to accelerate the uptake of innovations in healthcare, like the England NHS Innovation Accelerator3, and the Madrid-MIT+Visión Consortium4.

Senior leaders, fellows and students from different disciplines are establishing new ways of collaborations to catalyse the adoption of innovations and “make evidenced based healthcare innovations more widely available to patients3.

Evidence-based healthcare can be conceptualized as clinical decision making that considers:

. the best available evidence; . the context in which the care is delivered; . the client preference; . the professional judgment of the health professional (Pearson 2014).

There are a number of models that attempt to represent the components of evidence-based healthcare to facilitate understanding, analysis, improvement, and/or the replacement of the process as it is currently practiced (Stevens, 2005; Dawes et al., 2005; Stetler, 1994; Pearson, 2005).

According to Pearson (Pearson et al., 2012), translation research “is as complex and as frequently misunderstood as evidence-based healthcare”, and the dominant view overvalues the discovery research into application through the conduct of clinical trials, while underestimate the conduct of other important activities that are needed to put the generated evidence into action.

3 https://www.england.nhs.uk/ourwork/innovation/nia/ 4 http://mvisionconsortium.org/

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BOX 5: Multidisciplinary teams to translate evidence-based healthcare

Multidisciplinary research involves ‘‘not only the integration of discipline- specific approaches, but also the extension of these to generate fundamentally new conceptual frameworks, hypotheses, theories, models, and methodological approaches that transcend their disciplinary origins’’. (Hall et al., 2012)

However, “multi-layered, and stage-dependent processes creates new challenges in evaluating the processes, outcomes, and skill acquisition of members of multi-disciplinary teams”. (Wooten et al., 2013)

Translation of evidence-based healthcare requires bridging the following gaps:

1. “Translating the questions that arise out of the need for knowledge in the “real world” into discovery research (gap 1); 2. Translating the findings of discovery research into clinical or policy application through clinical or policy research (gap 2); 3. Translating the findings of clinical or policy research into action at the clinical or policy level (gap 3).

Integrating these three translation gaps into a model (for chronic care) of evidence-based health appears to clarify and reconceptualise the complexities of improving health outcomes through translating knowledge into action.” (Pearson, 2012)

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1.1.6 Motivations and structure of the research work

The motivation to provide an answer to the challenges presented in this section is the result of dynamic and heterogeneous collaborations, established in the last 10 years, with a variety of healthcare professionals involved in the care of chronic diseases. These collaborations took place in an international context, mostly European.

The need to find a way to productively and effectively involve and coordinate the different stakeholders of the healthcare domain encountered in all these years has been continuously growing and has motivated the research work carried out and reported in this document.

BOX 6: Motivation of the research work

In conclusion, there are several actions to improve the adoption of innovations from healthcare systems that are tackling the epidemics of chronic diseases:

. Translate Evidence-Based Healthcare (EBH) into actionable knowledge: wide and successful adoption of effective models of care is only possible when research findings can be translated. In order to transform knowledge and evidence into action, the way EBH is valued, synthesized, transferred and delivered is crucial. This means identifying a conceptualized model of care, and a suitable knowledge translation process, from discovery to intervention development, from development to delivery. . Face the complexity of healthcare through multidisciplinary research: once concepts are well defined, it is then possible to understand which domains and disciplines are (or can be) involved, in order to better analyse the way effective interventions can be put in place. . Identify a systematic approach to support effective implementation of healthcare interventions through innovation, in order to bridge the gap between health service development and innovation and unbind the potential of the synergies between these domains.

The framework proposed in this research work is a structured contribution to achieve these improvements.

The document is structured in different chapters to explain the research process, as shown in the figure below.

Chapter 1 has introduced the problem of the burden of chronic disease and the need to identify effective translation of evidence based healthcare into actions, through the support of innovation. The remainder of this chapter further elaborates on the analysis of the problem from a multi-domain and multi-

INTRODUCTION disciplinary perspective, with the aim to identify elements and factors that could make a positive impact to the problem, and to understand the limits and the barriers that so far have prevented this to be achieved.

In chapter 2, the research hypotheses and objectives of the research work are proposed.

In chapter 3, the methodological approach and the activities carried out to verify the hypothesis, as well as the methods and materials selected to implement these activities, are described.

In chapter 4, the results achieved are presented. Specific results have been reached for each hypothesis, and their description is provided accordingly.

Finally, in chapter, the results achieved are analysed, and a discussion on the verification of the hypothesis is presented. The chapter concludes with a description of the original contributions of this research work and with a reflection on the research directions that will be taken in the future.

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Multi-domain and multi-disciplinary background analysis

In this section, the problem of how CD management can benefit systematically and sustainably from innovations is analysed from different perspectives.

A top-down analysis has been carried out.

. First, existing official reports on health systems and policies are analysed, to show the elements that a model of chronic care should present. . Afterwards, evidence on the effectiveness of existing models of chronic care is described. . The role that research and development and innovation (R&D&I) should play in this problem is then described, . The eHealth paradigm, as an umbrella for catalysing and attracting innovation for healthcare, is later shown. . Finally, existing relevant activities on how engineering societies are contributing to the problem, are described.

1.2.1 Existing initiatives in tackling chronic diseases

The World Health Organization (WHO) defines chronic disease management as the “ongoing management of conditions over a period of years or decades” (WHO, 2013). Policy-makers across Europe and all over the world are searching for interventions and strategies to tackle chronic diseases.

The European Observatory on Health Systems and Policies, on behalf of the WHO, published important reports over the last years on this subject.

In the Caring for people with chronic conditions: A health system perspective report, issued on 2008, the authors elucidated the understanding of the systematic dimensions of policy-making in the field of chronic disease (WHO Regional Office Europe, 2008).

In the Managing Chronic Conditions – Experience in eight countries report, published in the same year, the authors recognized that for all the countries “facing unprecedented burden on their healthcare systems, it is important:

. To use new ways of working with all stakeholders, to find solutions (WHO Regional Office Europe, 2008); . Patients and their families need to be partners rather than passive patients; . That all staff need to be viewed as part of the solution and encouraged to innovate and search for better ways of delivering appropriate care. . Many of the diseases and their complications can be prevented by taking early measures and to encourage bad habits cessation;

INTRODUCTION

. ‘Lessons learnt” must be expressed in more than new care pathways but rather in new ways to prevent diseases and complications”.

In the following report, published on 2010, Tackling Chronic Diseases in Europe – Strategies, interventions and challenges, it is recognized that, differently from previous years analyses, CD are not only a problem of rich and elderly population, they represent a serious issue also for poor as well as young and middle-aged people and the economic implications are serious too (WHO Regional Office Europe, 2010).

The book provides more explicit reference to strategies and interventions that policy-makers have at their disposal to tackle chronic diseases. In particular, it is documented the need for:

. Prevention and early detection strategies: this includes primary, secondary or tertiary approaches and research suggest that broad combination of multiple interventions is most effective, however, their cost-effectiveness may considerably vary according to regional context and target population and they are far from being well developed. . Creation of new provider qualifications and settings: traditional tasks that physicians and nurses were used to execute, have been extended by new functionalities (e.g. coordinating roles, group practices, medical polyclinics) and consequently new professions (e.g. nurse practitioners, community nurses). Therefore, a need for well-targeted training, particularized at all the levels of professional hierarchy, is demanded to speed up the process for creating new qualifications, together with new structures and settings. . Research that builds on early results to justify investments and inform future decisions, is also demanded in this report. . New disease management programmes: over the last years, they have been introduced in many European countries to improve care and contain costs. However, there are few rigorously designed large-scale population-based evaluations, while small studies suggest promising results; a greater patient satisfaction and adherence to treatment has been also observed, suggesting an overall improvement of patient’s behaviour. Insufficient and inconclusive evidence on medical outcomes and cost-effectiveness is described: economic evaluation studies are cost focused, rather than costs/benefits and more collaboration from providers and insurers, to make data available for research and evaluation, is needed. . Integrated care models: it is rare that CDs can be treated in isolation, patients often have several CDs or conditions at the same time and care is provided by multiple actors and providers. Several initiatives have been set up to reduce the gaps between primary care and hospital services: also in this case, evidence is limited and therefore effectiveness of these projects is not clear (self-management support, decision support and delivery system design seem to be effective but there is a lack of large-scale population- based studies)

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The report concludes with some suggestions:

. Medical innovations could improve treatment of CDs but there are difficulties in terms of marketing authorization and reimbursement. . More attention is to be paid by policy makers on relating goal-setting and benefits since they become apparent only after several years from their investment. . The release of the full potential of ICTs is another important aspect suggested by the report and solutions for translating the vast amount of data into meaningful information to be used by health professional are needed: however, also in this case evidence is weak and there are only a few rigorous studies on effectiveness and cost-effectiveness. . To include evaluation as integral part of CD management programmes and better information to make better informed decisions can be only provided if existing data are immediately made available for research.

In terms of future research needs, the report mentions:

. a more rigorous and holistic research to design strategies and evaluate them in terms of appropriateness, effectiveness and cost-effectiveness, to support the identification of what makes an approach successful or failing; . adoption of ICT to store vast amount of information to be translated into meaningful information for professionals, . New methods for ensuring fast access to effective technologies and proper comparative evaluations.

In 2014, the report Assessing chronic disease management in European health systems-concepts and approaches was issued (WHO Regional Office Europe, 2008), with the aim of providing some answers to the questions raised by the 2010 report.

The edition of the report was always coordinated by the European Observatory on Health Systems and Policies, but as a result of a specific project funded by the European Union, the DISMEVAL (Developing and validating Disease Management EVALuation methods for European health care systems), “to develop new research methods and generate the evidence base to inform decision making in the field of chronic care”.

In this report:

. More emphasis is given to the societal aspects and costs resulting from direct health outcomes, such as increased absenteeism and reduced work productivity, and the exclusion of people with established diseases from active participation in society. . The importance of care to include enhancement of functional status and quality of life and minimization of distress symptoms, and the importance of having an active patient that is co-producer of care and that is placed at the centre of a delivery model that involves coordinated inputs from a variety of

INTRODUCTION

health professionals is finally recognized as the most important need to optimize health outcomes, . The need of “a unified framework for assessment to better understand the diverse range of contexts in which new approaches to chronic care are being implemented, and to evaluate the outcomes of these initiatives”, is recognized.

The report then highlight the importance of defining disease management as the combination of the following components:

1. “an integrated approach to care or coordination of care among providers, including physicians, hospitals, laboratories and pharmacies; 2. patient education; 3. monitoring or collecting patients’ outcome data for the early detection of potential complications (Krumholz et al., 2006)”.

Coherently to this, the review that is done in this report shows that strategies that involve multiple organizational aspects, that are set in the community and incorporate a multidisciplinary team approach are more likely to be effective.

Some fundamental issues remain, according to the report, consisting in the need of:

. developing a system-wide model of care; . reducing structural barriers between sectors, which are impeding further progress in advancing service delivery; . enabling systematic use of clinical information systems for CD management; . incorporating the perspective of an actively engaged “modern patient”; . providing the context to enable innovation.

The report concludes highlighting the importance of understanding whether approaches to better care of CDs should be considered as:

1. series of interventions that must be cost-effective and financially sustainable

or, alternatively,

2. “a complex strategy to innovate and implement long-lasting change in the way services in the health (and social care) sectors are being delivered and that involve multiple changes at multiple levels”.

The authors, based on the evidence shown in the report, suggest to focus on the latter and thus demand for continuous research activities (and investments) alongside the development and implementation of innovative services, to ensure that evaluation properly inform decision-making on service development, and generate appropriate conclusions about programme effectiveness.

INTRODUCTION

The findings highlighted in the above reports have been also supported by key opinion leaders in the health care sector.

Rafael Bengoa, former health commissioner of the Basque Country, advisor of the United States President Barack Obama on healthcare plan and politically independent5, reformed the Basque public health care system with a long-term and ‘big’ plan, to use the full potential of a single-payer system (Bengoa, 2013). This reform was driven by a variety of projects framed as health service research in order to evaluate processes and outcomes and provide evidence for improvements. This approach was justified by the aim of achieving more collaboration and proactivity in the HC system.

This reform (represented in Figure 7) followed the logic of the Chronic Care Model (CCM), but through a strategy of policy level agreement structured in terms of:

. Favourable policy environment: achieving scale in a community requires a narrative on chronicity at policy level, in order to drive transformation process as ‘organic’, and thus implying a cultural change, rather than using a regulatory and legislative approach in the first instance. . Stimulating system thinking with new models of care: the change management agenda must be driven by the introduction of new models of care that help to create local systems of care. The CCM was used as reference not only as a guidance but, most importantly, to stimulate ‘system’ thinking, population health perspectives and redefinition of the work among team members. . Aligning bottom-up and top-down ‘integrators’: care management processes (i.e. ‘integrators’) are needed to support coordination and integration of care in clinical terms, rather than in managerial and structural terms. Bottom-up interventions aim at involving clinical and nursing teams in the change process. Top-down interventions, in turn, resemble a more traditional approach since they are needed for standardized approach across the health care system towards reduction of variability of care and fragmentation (in terms of human and financial resources): joint commissioning and joint decision making mechanisms are promoted in this sense. . Promoting a distributed leadership approach: bottom-up processes are promoted, to support the engagement of new health care professionals, the replication and scalability of successful projects and reinforcement of future continuity (as top-down managed projects can “disappear” if their political promoters are replaced following elections). . Avoiding ‘Telesilos’: the use of digital and information technologies is recognized, as key integrators between level of care. However, technologies must not be used as a replication of existing organisational models of

5 http://elpais.com/elpais/2012/11/30/inenglish/1354291930_281211.html

INTRODUCTION

managing disease and therefore reinforce their silos effects and defects, they must be rather used in a complementary fashion.

Figure 7- Aligned management processes as integrators (adapted from Bengoa, 2012).

Julio Mayol, chief innovation officer at the Madrid San Carlos Hospital, recognized as one of the 500 most influencing person in Spain6 and one of the 10 most influencing clinicians (in Spain) in Twitter7, stated, in a recent interview on the m-health competence centre report8, that:

. “Our ultimate goal is transforming health systems” and make them patient centred. . The concept of empowered patients need to be better defined, because having access to information that allows making decisions is not enough: information about healthcare services is what current systems provide, while patients and citizens need information about outcomes and results of such services. . Sectors not directly related to health care have the capacity to provide new answers to old problems that are still unsolved,

Following on the last bullet point, an outstanding example of positive inspirations and contaminations from other disciplines that caused important consequences in health related policies is the work done by the Behavioural Insight Team.

6 http://boletindenoticias.fundacionbotin.org/Ciencia/septiembre2014/pdfs/entrevista1.pdf 7http://www.rmedica.es/edicion/176/los-10-hombres-mas-influyentes-de-la-sanidad- espanola 8 http://www.mobilehealthglobal.com/in-the-news/interviews/50/interview-with-julio-mayol

INTRODUCTION

This group has been created by the United Kingdom Cameron’s government in 2010, “started inside Downing Street as the world’s first government institution dedicated to the application of behavioural sciences”.

Old objectives (“same than before”) like improving cost-effectiveness of public services, easing them for citizens, improving outcomes through more realistic model of human behaviour to policy and, wherever possible, “enabling people to make ‘better choices for themselves”, have been tackled by redesigning public services and drawing on ideas from the behavioural science literature.

They are also highly empirical; they “test and trial these ideas before they are scaled up”. This enables them to understand what works and (importantly) what does not work.

Finally, they define themselves as a “multidisciplinary strong academic grounding staff” (economics, psychology, randomised controlled trial design, government policy-making).

This group, informally known as the nudge unity, because it makes use of the nudge theory, co-created by one of the members in 2008 (Sunstein and Thaler, 2008), as summarized in the Financial Times9, let the government save about 300 millions of pounds in five years, through initiatives that included, among others, public health campaigns.

1.2.1.1 In Summary

There is a need for models of chronic care that are:

. Efficient and cost-effective, . providing information about outcomes and results to “activated modern citizens”. . systemic and evidence-based, while pragmatic and affordable, . enabling multidisciplinary, multi-actor synergies, new ways of working and new professional figures, . providing early result research and continuous innovation, and informing decision makers to justify future investments, . stimulating system thinking, bottom-up integration, as well as positive and extra-sectorial “contaminations”, . reducing barriers between sectors and care providers, . systematically using information systems and . providing the context to enable innovation.

9http://www.ft.com/cms/s/8e6a38ae-306d-11e5-8873- 775ba7c2ea3d,Authorised=false.html?_i_location=http%3A%2F%2Fwww.ft.com%2Fcms%2 Fs%2F0%2F8e6a38ae-306d-11e5-8873- 775ba7c2ea3d.html%3Fsiteedition%3Duk&siteedition=uk&_i_referer=#axzz3hBi1XArD

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Figure 8 - "Words cloud" for Healthcare Systems and Chronic Care. The cloud has been generated from the most recurrent words of section 1.2.1.

1.2.2 Existing effective and affordable models of chronic care

Improving disease management at a system level requires a healthcare delivery model which is appropriately designed and organised to respond to the common care needs of chronic patients. Such a model would be characterised by the anticipation and planning of the care needs of the patient, by the support to the role of the patient in the self-management of his/her own disease, by the individualisation of the care plan to his/her personal needs and values, by the coordination between different healthcare providers, and by the provision of services based on evidence (Wagner et al. 2001).

INTRODUCTION

The current reference models are:

1. The Chronic Care Model 2. The Innovative Care for Chronic Conditions Framework 3. The Kaiser Pyramid 4. The British King’s Fund Pyramid

The Chronic Care Model (CCM) is the main reference model for chronic illness: all the others represent an extension or an adaptation to it.

This model, and its adaptations (Wagner et al. 1996a, Ham 2010, Nuño et al. 2012), represents a “functional blueprint or template” to guide change towards new models of care (Glasgow et al., 2001), and it also defines examples of tools and interventions that can be used to act at the different parts of the healthcare system.

The CCM has been used in a variety of environments to support the reorientation from acute to chronic care (Singh and Ham, 2006). A systematic review found that multifaceted interventions were effective in improving the process of care for patients with diabetes (Renders et al., 2001); another systematic review reported on improvements on at least one process or outcome measure for diabetic patients (Bodenheimer et al., 2002) and on evidence of improved costs and lowere use of services in the case of heart failure, asthma and diabetes. A meta-analysis found that no single element of the model is crucial to improve outcomes (Tsai et al., 2005), and another work confirmed that is rather the cumulative effect of all the elements of the Model that is beneficial on outcomes (Bodenheimer et al., 2002).

A study by Mackey et al. 2012 showed better adherence to medication to be significantly related to receiving care more consistent with the CCM (Mackey et al, 2012). Mackey et al. 2012 also reported on results from previous studies showing a positive result of implementing elements of the CCM such as case management, self-management support, shared decision making, or a stronger therapeutic alliance between patient and physician, on medication adherence for depression and type 2 diabetes.

Support to self-management by chronic patients is one of the main elements of the CCM. As regards to the evidence on self-management support programmes, the review by Chodosh et al. 2005 found positive effects on indicators of control of disease for diabetes and hypertension, but not for osteoarthritis (Chodosh et al, 2005). Regarding self-management support programmes led by lay leaders (peer-to-peer), a systematic review found significant (although small) effects on the frequency of aerobic exercise, self- efficacy, cognitive symptom management and self-reported health, for diabetes, hypertension, arthritis, and chronic pain (but no significant effects on psychological health, symptoms or health-related quality of life), which however, did not significantly change healthcare use (Foster et al. 2007).

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In 2010, Ham proposed to build on the CCM but giving “further priority to recognize the role played by patients, with their families and carers, and to support health care professionals in change their practices”, in line with the CCM. The proposal consisted in “ten characteristics of a high performing chronic care system10” and four strategic actions11 that have to be implemented at different levels (Ham, 2010). In this exercise, Ham was helped to “crystallise his thinking” by Ed Wagner and Rafael Bengoa, among others. It is a way of synthesizing the CCM in such a way that can serve as practical guidance to policy makers and healthcare leaders involved in the improvement of healthcare delivery.

Among the numerous adaptations of the CCM, the Innovative Care for Chronic Conditions (ICCC) framework (Epping-Jordan ET AL., 2004) is the most important; created by the same authors of the CCM, it adds a health policy dimension based on evidence-based decision making and population health. The authors suggest that the CCM has intrinsic capability to be applied to prevention programmes too.

The Kaiser Pyramid has a population approach, based on the CCM, which classifies patients in three main risk categories and identifies the type of care accordingly. Doctors from primary and secondary care share the same budget and function within multi-speciality centres which also house nurses, pharmacists, laboratory technicians, radiology staff and others. People with long-term conditions are stratified according to need, with intensive management targeted at those at highest risk (Feachem et al., 2002). This service delivery model include some form of case management as a component of care.

The British King’s Fund Pyramid is the most interesting adaptation of the Kaiser Pyramid, where the three levels are approached from a twofold strategy that combine the health dimension with the social one.

The London Health Observatory, in the Review of UK and International frameworks for improving care for people with long term conditions (Ham, 2006), suggested that:

. CCM and its extensions are the most common frameworks for conceptualising effective components of care for people with long-term conditions . the Kaiser pyramid illustrate a good approach for service delivery.

10 1) ensuring universal coverage; 2) provision of care free at point of use; 3) delivery system focused on prevention; 4) priority given to self-maanagement and to 5) primary care; 6) population management emphasized; 7) care integrated to enable primary care teams to access specialist advice and support; 8) exploit the benefits of IT; 9) ensure effective coordinated care; 10) link the 9 characteristics into a whole strategic approach to change (Ham, 2010) 11 1) physician leadership; 2) measuring patient outcomes; 3) best way of incentives; 4) community engagement

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More in detail:

. “This review suggests that the Chronic Care Model and the related Innovative Care for Chronic Conditions Model are the most common frameworks for conceptualising effective components of care for people with long-term conditions. . The Kaiser pyramid of care appears to be used throughout the developed world to conceptualise service delivery. . While a number of other approaches guide service delivery, these tend not to be conceptualised as formal models, nor are their components clearly articulated”.

As regards evidence:

. “There is limited high quality evidence about the impact of any model. . Although components of the Chronic Care Model have been studied extensively and a detailed evaluation has been undertaken in the US, it is still unclear whether this model is any more effective than others. . This is largely because other models are not well conceptualised or described. . There is also limited information about whether all components of the Chronic Care Model are necessary or effective. . There is evidence that improvement programmes which aim to implement the Chronic Care Model can have a sustainable impact on quality of care and some clinical and resource outcomes. . The relative merits of each component of the model, and the extent to which these are implemented effectively by healthcare organisations, is still under review. . There is almost no evaluative information about any other broad chronic care framework. Evaluations of specific models of service delivery, such as the Kaiser and Evercare approaches, are available. These suggest that specific service delivery models may have some impacts on quality of care and healthcare resource use, however most high quality evidence is drawn from the US health system.”

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Figure 9 – “Words Cloud” for "Models of Chronic Care". The cloud has been generated from the most recurrent words of section 1.2.2.

1.2.2.1 The role of innovation in the CCM

When introducing the CCM, the same Wagner, making reference to the IOM report, identified the deficiency of assuring quality of care for chronic conditions caused by:

“

1. Quality gap between the increased demands on medical care from the rapid increases in chronic disease prevalence and the complexity of the underlying science and technology; 2. The inability of the system to meet these demands because of our poorly organized delivery system and constraints in using modern information technology.

INTRODUCTION

”In the recent The Chronic Care Model and Technological Research and Innovation: A Scoping Review at the Crossroads, it is recognized that “little is known about how and to what extend CCM and ICT research inform each other to leverage mutual strengths” (Gammon, 2015). In this review, it was found that interventions relies mostly on “old-fashioned” technologies and it is difficult to decipher how CCM is guiding intervention design. “Challenges in facilitating CCM components through ICT included poorly designed user interfaces, digital divide issues and lack of integration with existing infrastructure”.

The CCM is a highly influential guide for health care development, which recognizes the need for alignment of system tools such as ICT. Yet, it seems that a major critical point is still the synergy between the domains of “health service development”, on the one side, and of “high-tech innovation” on the other side.

The facilitation and improvement of this synergy needs urgent attention by policy makers and funding agencies and requires the joining of forces between both high-tech innovation expertise, and experts in the chronic care system redesign.

In a systematic review of the role of technology in the chronic care model applied to diabetes (Siminerio, The Role of Technology and the Chronic Care Model, 2010), it was analysed how each dimension of the CCM can be supported by technologies or studies related to them:

. in the HC system dimension, the role of IT registries to determine quality improvements, . In the community dimension how web sites and social media may be used to disseminate disease specific information and create virtual communities, and so forth with the other dimensions.

The author concludes recognizing the need to seek for innovative technology programs and the fact that to date technology still has a limited role in the delivery of care and treatment, while it has the potential to overcome routine delivery barriers: integrating technology into an interoperable framework is crucial to enable chronic care management in a cost-effective and scalable manner.

(Gretchen et al., Diabetes Care, 2006) performed a RCT of a multi-faceted diabetes care intervention, based on the CCM (Plat). As a premise it was recognized that few efforts exist to implement multifaceted approaches to improve quality, despite the demonstration of their effectiveness (Wagner, 1996a; Wagner 1996b; Wagner 2001; Wagner et al., 2001; Wagner 2005); the study demonstrated that outcomes for people with diabetes can be improved through the CCM.

In the In the IOM report Health Literacy, eHealth, and Communication: Putting the Consumer First, the round table members noted that the eHealth Initiative was

INTRODUCTION

guided by Wagner’s vision of the CCM and used as the “blueprint” for eHealth to support chronic illness (Hou, 2010). For enhanced use with the CCM, the authors suggest specific components highlighted in the information technology and communication literature including use of the Internet for health information, social networking, telehealth, mHealth (including wearable devices), electronic health records (EHRs), and electronic personal health records/patient portals (PHRs).

In The eHealth Enhanced Chronic Care Model: A Theory Derivation Approach (Gee et al. 2015) , a review research on eHealth tools that support CCM was done, to present a revised eHealth Enhanced CCM (eCCM), by identifying for each component of the CCM those eHealth tools that can make important contributions and specifying the model modifications accordingly.

1.2.2.2 In Summary . the Chronic Care Model and the related Innovative Care for Chronic Conditions Model are the most common frameworks for conceptualising effective components of care for people with long-term conditions. . There is limited high quality evidence about the impact of any model. . To date there are few attempts to systematically use Innovation to support and complement, rather than replicate and modify, the adoption of the Chronic Care Model in all this stages, dimensions and phases. . The CCM can be used as a reference model for enabling system thinking, but in the future new models could provide better evidence.

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Figure 10 – “Words Cloud” for CCM and Innovation. The cloud has been generated from the most recurrent words of section 1.2.2.1.

INTRODUCTION

1.2.3 R&D&I: the role of Chronic Care in the Europe 2020 initiative, the Work Programme, the EIP on AHA and the EIT-Health

The Horizon 2020 is a European Union (EU) programme with about €80 billion of funding, available over 7 years (2014 to 2020). It is the financial instrument that implements the Innovation Union12, “a Europe 202013 flagship initiative aimed at securing Europe's global competitiveness, having the political backing of Europe’s leaders and the Members of the European Parliament on putting R&I at the heart of the EU’s blueprint for smart, sustainable and inclusive growth and jobs.”

Figure 11 - Structure of the Innovation Union within the Europe 2020 agenda (adapted from Universidad Politécnica de Madrid, 2013).

Healthcare related activities represent an important part, being the 15% of the financial funds, as part of the SC pillar, being included as a standalone “Innovation Partnership” on Active and Healthy Ageing

1.2.3.1 Health, Demographic Change and Wellbeing

The Horizon 2020 is composed of three main pillars: Excellent Science (ES), LEveraging IndusTrial leadership (LEIT) and tackling Societal Challenges (SC). Health, demographic change and wellbeing challenge is the first part of the SC pillar (SC1), aiming to “keep older people active and independent for longer and

12 http://ec.europa.eu/research/innovation-union/index_en.cfm 13 http://ec.europa.eu/europe2020/index_en.htm

INTRODUCTION

supports the development of new, safer and more effective interventions, and […] to the sustainability of health and care systems”14.

In the introduction of the SC1 Work Programme (WP) for 2014-2015, funding proposals with a total budget of approximately EUR 1.21bn, it is clearly stated that:

. “The choice to focus on personalising health and care is informed by the ageing of the European population, an increasing communicable and non- communicable disease burden and the fall-out from the economic crisis. . Topics in the call are divided into 7 areas which reflect the need for a translational and integrated approach to the challenge, providing support both to longer and mid-term research as well as to shorter term innovation activities.” . “Taken together, work to be supported by the different topics (e.g.: Integrated Care, etc.) will […] test and demonstrate new models and tools for health and care delivery.”

Topics in this work programme also respond to the priorities of:

1. The EIT- European Institute of Innovation and Technology for Health (EIT- HEALTH). The EIT, has been created to enhance Europe’s ability to innovate by integrating, for the first time at EU level, education and entrepreneurship with research and innovation. The main operational arm of the EIT is its Knowledge and Innovation Communities (KICs)15. Through them the EIT develops and tests a new model of how innovation is approached, managed, financed and delivered in Europe. The EIT's three initial KICs were established in 2010 to address Climate change, Sustainable energy and ICT innovation. In December 2014, the EIT has launched the KIC for healthy living and active ageing. 2. The European Innovation Partnership on Active and Healthy Ageing (EIPonAHA). The EIPonAHA is the first pilot of the European Innovation Public-Private Partnerships (PPP), proposed in the Europe 2020 Strategy, to tackle innovation barriers for major societal issues. The EIPonAHA aims to identify and remove barriers to innovation for active and healthy ageing, through interdisciplinary and cross-sectorial approaches.

14http://ec.europa.eu/programmes/horizon2020/en/h2020-section/health-demographic- change-and-wellbeing 15 http://eit.europa.eu/activities/innovation-communities

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Figure 12 – “Words cloud” for the Horizon 2020. The cloud has been generated from the most recurrent words of section 1.2.3.

1.2.3.2 EIP on AHA

The European Innovation Partnership on Active and Healthy Ageing (EIP on AHA) launched by the European Commission in 2011 under the Innovation Union policy initiative is an attempt to address the challenges of ageing in Europe (European Commission, 2011). It provides a platform for stakeholders to join forces, learn from each other and implement interventions that will help improve the quality of life and health status of European citizens and the sustainability of health and care systems, while contributing to economic growth in Europe. Besides these three objectives, also called the "Triple Win", the ultimate goal of the EIP on AHA is to increase the healthy lifespan of European citizens by two healthy life years (HLY) by 2020 Europe (European Commission, 2011).

The EIP on AHA provides fora for stakeholders to join forces, learn from each other and implement interventions to improve the quality of life and health status of European citizens and the sustainability of health and care systems, while contributing to economic growth in Europe16.

The Partnership was established in 2012, and is now in its implementation stage with more than 3.000 partners involved (300 leading organisations are actively forming coalitions and consortia, covering stakeholders from all EU Member States, representing approximately 1,000 regions and municipalities). “The Strategic Implementation Plan of the EIP AHA focuses on promoting people oriented, demand driven innovation for ageing well, which brings tangible and proven benefits to end-users, helps health and care systems to contain costs

16 EIP-AHA, official web page: http://ec.europa.eu/research/innovation-union/ index_en.cfm? section=active-healthy-ageing. Accessed 27/06/2014.

INTRODUCTION and unlocks business opportunities on European scale Europe (European Commission, 2011)”

“Partners are working in two main strands16:

1. the Reference Sites, which are 32 regions, cities, or integrated hospitals/care organisations that implement a comprehensive, innovation- based approach to active and healthy ageing and can give concrete evidence and illustrations of their impact on the ground; 2. the 6 Action Groups, which over 3,000 partners have joined by submitting a Commitment (over 500 commitments received). The Action Groups focus on sharing information and solutions on how to overcome bottlenecks, pooling knowledge and resources and acting towards shared goals. They are: . A1 Prescription and adherence to medical plans. By 2014: To deliver tangible adherence approaches for various chronic disease areas in at least 30 EU regions. . A2 Personalised health management and falls prevention. By 2015: To have in at least 10 European countries (15 regions) validated and operational programmes for early diagnosis and prevention of falls. . A3 Prevention and early diagnosis of frailty and functional decline. By 2015: to have validated programmes for prevention of functional decline and frailty (with first action focused on malnutrition) among older people supported by tools, networks and information reaching at least 1,000 care providers across the EU. . B3 Replicating and tutoring integrated care for chronic diseases, including remote monitoring at regional level. By 2015: Availability of programmes for chronic conditions/case management (including remote management/monitoring) serving older people in at least 50 regions, available to at least 10% of the target population (patients affected by chronic diseases in the regions involved). By 2015-2020: Based on validated, evidence-based cases, scale-up and replication of integrated care programmes serving older people, supported by innovative tools and services, in at least 20 regions in 15 Member States. . C2. Development of interoperable independent living solutions. By 2015: Availability of key global standards and validated implementations of interoperable platforms, solutions and applications for independent living, and also, availability of evidence on the return on investment of these solutions and applications, based on experience involving at least 10 major suppliers, 100 SMEs and 10,000 users. . D4 Innovation for age-friendly buildings, cities & environments. By 2012: launching, based on the WHO age friendly cities initiative, a network of major cities/regions/municipalities committed to deploying innovative approaches to make their living environment more age friendly, including the use of ICT solutions.”

INTRODUCTION

In order to 1) make and 2) measure overall impact of the EIPonAHA, the following projects have been created, working transversally over the Action Group and Reference Sites:

1. The scaling-up strategy, Its ambition is “To mobilise sufficient resources and expertise, which combined with the collection of good practices and Reference Sites experiences, will ensure implementation of innovative solutions for active and healthy ageing on a European scale.” 2. The 'Monitoring and Assessment Framework for the EIP on AHA (MAFEIP) project'17, launched jointly by the European Commissions' (EC) Joint Research Centre, Institute for Prospective Technological Studies (JRC IPTS), the Directorate General for Communications Networks, Content and Technology (DG CNECT), and the Directorate General for Health and Food Safety (DG SANCO). Aim of this project is to create “a framework that can help estimating the health and economic outcomes of a large variety of social and technological innovations in the health and care sector targeting active and healthy ageing.” These innovations are being developed and implemented by a total of 517 commitments (groups of stakeholders participating in the EIP on AHA) across all EU-countries (and beyond), organised in the six thematic AGs (Table 1 and Figure 1)” (Abadie et al., 2014).

Figure 13 - Overview of the EIPonAHA Action Groups and number of Commitments (adapted from Abadie et al., 2014).

17 http://is.jrc.ec.europa.eu/pages/TFS/MAFEIP.html

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Figure 14 - Stakeholders and Countries of the EIP on AHA (adapted from Boehler and Abadie et al., 2014).

The MAFEIP project has developed a web-based tool which rests on a Markov process, and aims at estimating the impact of the EIP on AHA activities on health and on the sustainability of health and social care systems. More precisely, the MAFEIP-tool allows estimating the change in quality adjusted life expectancy related to the activities carried out in the EIP on AHA and the estimated impact of a social or technological innovation on health and social care expenditure in a particular context (Boehler, 2015a, Boehler, 2015b).

Figure 15 – “Words Cloud” for EIP on AHA. The cloud has been generated from the most recurrent words of section 1.2.3.2.

INTRODUCTION

1.2.3.3 EIT-HEALTH EIT Health is a consortium of more than 50 core partners and 90 associate partners from leading businesses, research centres and universities from across 14 EU countries.

Designated as an EIT Knowledge and Innovation Community (KIC) on 09 December 2014, its goal is “to contribute to increasing the competitiveness of European industry, improve the quality of life of Europe’s citizens and the sustainability of healthcare system18”.

With a budget of 2 billion EUR over 2015-2025, “it will invest in Europe’s best entrepreneurial talents and creative minds to foster the development and commercialization of smart product and service solutions in the health sector, addressing the challenges imposed by demographic change and ageing societies”.

EIT Health is guided by the understanding that the societal challenges do not only present a risk but also provide a multitude of new opportunities if knowledge and networks are fully leveraged across all health-related sectors and new ideas are rapidly turned into solutions. Considering innovation as the basis for growth, competitiveness and social well-being.

Figure 16 - The 3 Strategic Challenges, Business Objectives (in green) and Scenarios (in blue) of the EIT-Health (adapted from https://eithealth.eu/).

Addressing the challenges of demographic change and ageing societies, EIT Health will focus investments on innovative products and services around three challenges: supporting patients in their desire for self-contained management of their health (Promote Healthy Living); ensuring they stay professionally and

18 https://eithealth.eu/

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socially connected and active even at old age (Support Active Ageing); ensuring better integration of healthcare services and provisions (Improve Healthcare). As regards the Improve Healthcare challenge, two business objectives have been defined: 1) improving healthcare systems, seeking solutions for “the integration of service delivery across different care modalities (primary, secondary and rehabilitation care, long-term) and sectors (social, health, informal, etc.); 2) Treating and managing chronic diseases, aiming to develop methods, solutions and concepts for improved treatment and management of chronic diseases.

Figure 17 – “Words Cloud” for EIT Health. The cloud has been generated from the most recurrent words of section 1.2.3.3.

1.2.3.4 In Summary The EU is funding research, through the Horizon 2020 instrument, recognizing the following aspects:

. Need for a translational and integrated approach . Support to longer, mid-term research as well as to shorter term innovation activities. . Test and demonstrate new models and tools for health and care delivery

The EU and European healthcare stakeholders are making huge efforts in reducing barriers to innovations (EIPonAHA) and accelerate innovations (EIT on Health). Through the EIPonAHA and EIT on Health it could be possible to:

. defining and discussing healthcare innovations with all types of stakeholders . assessing their potential impact through the MAFEIP project . assessing their maturity through the scaling up strategy . transforming Knowledge and Ideas into Products and Services . transforming Business Ideas into Market Opportunities

INTRODUCTION

1.2.4 The role of eHealth in Health and Social Care

In his PhD work on A model to develop a platform for personalized health applications (Salvi, 2014), Salvi made an extensive overview of how ICT has been used in healthcare, from the early decades XXth century, when radio was used to communicate doctors with patients, to elucidate how the concept of telemedicine has appeared and evolved in the 60’s-70’s decades, till the 80’s, where a shift from real-time to asynchronous applications took place, thus enabling data to be collected in digital form in a an initiating site and are aggregated and stored for subsequent transmission to a receiving site”.

Then he explained how the concept of telemedicine (defined by the Joint Working Group on Telemedicine in a report to U.S. Congress on January 31, 1997), started to become ambiguous due to the emergence of consumer technology ICT and of the internet, in terms of “its ability to identify a precise region of questions, expertise and support”.

The term tele-healt appeared as an answer to this ambiguity, covering systems and services that link patients with care providers to assist in diagnosing, monitoring, management and empowerment of patients with long-term conditions (chronic patients) (COCIR, 2010).

The rise of Internet and the possibility to integrate different services in different environments like homes, hospitals, pharmacies, but also laboratories, wellness centres etc. generated a vision where all these environments are connected through ICT, share data and collaborate to provide better health care.

The term under which this vision goes is electronic-health or eHealth. eHealth is an umbrella term that has been defined by Eysnbach as

“The intersection of medical informatics, public health and business, referring to health services and information delivered or enhanced through the Internet and related technologies.

In a broader sense, the term characterizes not only a technical development, but also a state-of-mind, a way of thinking, an attitude, and a commitment for networked, global thinking, to improve health care locally, regionally, and worldwide by using information and communication technology”

(Eysnbach, 2001). eHealth is related to an integrated health-care system through ICTs in a holistic approach: “telemedicine remains linked to medical professionals, while eHealth is driven by non-professionals, namely patients that with their interests drive new services even in the healthcare field mostly for their empowerment through access to information and knowledge"(Della Mea, 2011).

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The European Federation of Medical Informatics presented, in the report eHealth in Europe – Status and Challenges, a survey conducted through 10 questions within the EFMI members, about the “European reflections on the concept of eHealth and challenges to further development of eHealth in Europe” (Moen et al, 2012):

. eHealth concept: the common understanding is that eHealth involves (through design, development, implementation and evaluation) the adoption of ICT in the health system; . eHealth relates with cross-institutional and inter-disciplinary efforts and collaborations. . As regards services and applications provided by eHealth, the common understanding is that they are related with:

 technical and social infrastructure and connectivity to share information”,  efforts for data exchange,  interoperability in terms of terminology, ontology and standard developments,  legal and ethical issues for authentication, confidentiality and reliability;

. eHealth applications and services allows for “interaction between providers and patients across time and space given eHealth infrastructures and repositories” (e.g.: ePrescription, eReferral, eDischarge, eConsultations, eCoordination).

In terms of challenges for future deployment of eHealth, the authors recognize that they are heterogeneous and there could be a variety of way of interpreting this heterogeneity. They suggest to “zoom in” on the ‘strategy policy’, ‘technological’, ‘organizational’ and ‘professional’ ones, to “elaborate the perspectives for an integral or holistic perspective on eHealth” (Figure 18).

INTRODUCTION

Figure 18 - Basic Categories for eHealth challenges (adapted from (Moen et al., 2012).

The EFMI, in conclusion, support the need for “a shift from a strict ICT focus on ICT implementation to a comprehensive, holistic approach acknowledging that eHealth involves interplay of appropriate technical and social infrastructure, secure repositories and usable applications”.

In the work How can research keep up with eHealth? Ten Strategies for increasing the timeliness and usefulness of eHealth research, (Baker et al., 2014), it is acknowledged that since the definition of eHealth relies, in part, on technology (mHealth, telemedicine, ICT), its nature is affected by the rapid pace of technological change.

To overcome this issue and learn about how conducting research, the author suggests an “efficiency strategy” that includes:

1. “think small: conduct small studies that can target discrete but significant questions and thereby speed knowledge acquisition; 2. use efficient designs: use such methods as fractional-factorial and quasi- experimental designs and surrogate endpoints, and experimentally modify and evaluate interventions and delivery systems already in use;

INTRODUCTION

3. study universals: focus on timeless behavioural, psychological, and cognitive principles and systems; 4. anticipate the next big thing: listen to voices outside normal practice and connect different perspectives for new insights; 5. improve information delivery systems: researchers should apply their communications expertise to enhance inter-researcher communication, which could synergistically accelerate progress and capitalize upon the availability of ‘big data’; 6. develop models, including mediators and moderators: valid models are remarkably generative, and tests of moderation and mediation should elucidate boundary conditions of effects and treatment mechanisms. Quality strategies include: 7. continuous quality improvement: researchers need to borrow engineering practices such as the continuous enhancement of interventions to incorporate clinical and technological progress; 8. help consumers identify quality: consumers, clinicians, and others all need to easily identify quality, suggesting the need to efficiently and publicly index intervention quality; 9. reduce the costs of care: concern with health care costs can drive intervention adoption and use and lead to novel intervention effects (e.g., reduced falls in the elderly); and 10. deeply understand users: a rigorous evaluation of the consumer’s needs is a key starting point for intervention development”.

In conclusion,

. technologies and technological innovations have been influencing the way health care professionals have been interacting, . The need to define new concepts, domains and research areas, to keep up with the pace of the evolution of technological innovations, is continuous. . Therefore, it is important to understand the current healthcare context and its intersections with technologies and innovations, how it has been determined from its past and how is evolving towards the future. . To this aim, methods that help to represent and conceptualize the actual healthcare context, are needed.

In the work A Holistic Framework to Improve the Uptake and Impact of eHealth Technologies (van Gemert-Pihnen et al., 2011), the Centre for eHealth and Wellbeing Research (CEHRES) group made a literature search to identify potential and limitations of eHealth frameworks from 1999 to 2009, looking for the definition of a holistic approach towards development and integration of eHealth technologies in the healthcare sector.

They found that, despite their potential, a not clear relationship between eHealth visions, proposed strategies and research methods emerged, due to a conceptual approach focused on the rationale behind the frameworks, rather

INTRODUCTION

than focused on practical guidelines and on a more stakeholders-driven approach.

They finally propose a new holistic framework, the CEHRES Roadmap, to overcome these barriers, built on a participatory development approach, persuasive design techniques and business modelling, serving as an evidence- based roadmap (Van Velsen et al., 2011 and 2012).

The authors suggest that the CEHRES Roadmap can be used by the project management team (i.e.: the team involved in the design, implementation and evaluation of the technology) as an instrument through which stakeholders can debate to clarify areas that “would otherwise remain unanswered, unclear, or unknown”, and in which “technology is not considered as a tool or end in itself, but as a catalyst for innovation”.

To “support a discussion about the development of eHealth technologies” the group has created a Wiki19 where the CEHRES Roadmap is described. This space serve as “an open and collaborative approach to the development of eHealth technologies. It provides an expanding and continuously evolving collection of instruments and tools to assist developers, researchers and policy makers” (van Gemert-Pihnen et al., 2011).

19 available at http://ehealthwiki.org

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Figure 19 – “Words Cloud” for eHealth. The cloud has been generated from the most recurrent words of section 1.2.4.

1.2.4.1 In Summary . It is evident that technologies and innovations have been influencing the way health care professionals have been interacting and working. . In parallel there is an unmet need for defining new concepts, domains and research area. . It is important to understand the current healthcare context and its intersections with technologies and innovations. . To this aim, methods that help to represent and conceptualize healthcare context, are needed. . The eHealth paradigm, using “internal and external” methods, techniques and technologies, should help to:

 understand clinical knowledge,  represent and translate it,  properly communicate to all kind of stakeholders.

INTRODUCTION

1.2.5 The role of engineers in Health and Social Care

In this section the roles and the initiatives that engineering societies have officially undertaken in relation to accelerate the uptake of innovations to improve CDs Is explored. This is done by describing the activities of the IFMBE and EMBS societies.

1.2.5.1 The International Federation for Medical and Biological Engineering (IFMBE) Born in 1959, as a result of the 2nd International Conference of Medical and Biological Engineering, where “a group of medical engineers, physicists and physicians met to create an organization entitled International Federation for Medical Electronics and Biological Engineering”, at a time in which there were few biomedical engineering societies and workers, the IFMBE became a real federation when national societies of medical and biological engineers were formed, around mid-sixties. The objectives and the composition of the federation have grown and changed over the time. In the first years clinical engineering was a minor sub discipline while now this category represents almost the half of the total membership. The Federation has now “an estimated 120,000 members in 58 affiliated organizations”20.

These members belong to the field of Medical and Biological Engineering which, according to the IFMBE official website, “integrates physical, mathematical and life sciences with engineering principles for the study of biology, medicine and health systems and for the application of technology to improving health and quality of life. It creates knowledge from the molecular to organ systems levels, develops materials, devices, systems, information approaches, technology management, and methods for assessment and evaluation of technology, for the prevention, diagnosis, and treatment of disease, for health care delivery and for patient care and rehabilitation”.

The mission of the IFMBE is to encourage, support, represent and unify the world-wide Medical and Biological Engineering community in order to promote health and quality of life through advancement of research, development, application and management of technology.

The goals of the IFMBE are:

1. To function as the leader in representing the international community of medical and biological engineering; 2. To foster the creation, dissemination and application of medical and biological engineering knowledge and the management of technology for improved health and quality of life;

20 http://ifmbe.org/members/

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3. To promote the development of the medical and biological engineering profession, and the recognition and awareness of the profession by the public. 4. To advance collaboration between national and transnational societies, industry, government and non-governmental organizations engaged in health care and in biomedical research and its applications. 5. To recommend policies and provide guidelines in appropriate professional, educational and ethical areas. 6. To enable IFMBE to achieve its goals effectively, optimize the organizational structure and communication and enhance its finances”.

The IFMBE is organized in two main divisions,

. The Clinical Engineering Division (CED).

 “The IFMBE is the only international professional federation that has a CED focusing specifically on the life cycle management of healthcare technology and embracing all those who professionally practice in the clinical engineering field, whether in academic institutions, health care facilities, industry, business, voluntary sector, or government”.  The mission of the CED “is to advance worldwide learning, research, knowledge, deployment and communication of healthcare technology management within the clinical engineering community and its understanding by other stakeholders”21.

. the Health Technology Assessment Division (HTAD) 22:

 This division has been created to promote the importance of Healthcare Technology Assessment23 (HTA) within the biomedical and clinical engineering community  Within the “HTAD, the focus is mainly on the medical devices, the procedures, and the systems used in healthcare delivery, excluding vaccines, pharmaceuticals and clinical interventions.  The purpose of the HTAD is to support the process of decision- making in health care at policy, clinician and management levels by providing reliable and timely information on some or all of the evaluative dimensions mentioned earlier.  In this respect, HTA has been compared to a bridge between the world of research and the world of decision-making since assessment of currently adopted technologies can inform both research and adoption strategies.

21 Information extracted from: http://ifmbe.org/organisation-structure/divisions/clinical- engineering-division/ 22 Information extracted from: http://ifmbe.org/organisation-structure/divisions/htad/ 23 Health Technology Assessment is a multidisciplinary field of policy analysis. It evaluates “the medical, social, ethical, and economic implications of the development, diffusion, and use of health technology”, according to the International Network of Agencies for Health Technology Assessment (INAHTA). It is clear from this definition that the scope of HTA is very broad

INTRODUCTION

 In accordance with the broad concept of health technology, HTA can be applied to measure the potential consequences not only of medical interventions but also of organizational interventions, informing decision-makers on:

o potential effects on public health o Consequences on the healthcare system itself and its economy.

 As a result, evidence-based decisions are provided:

o depending on particular conditions of economic and health priorities and factors, o but also influencing the acceleration or slowing down of the diffusion of the technology in question at different levels of care and/or in different sectors of the health system”.

1.2.5.2 The Engineering and Medical Biological Society The IEEE Engineering in Medicine and Biology Society (EMBS) is the world’s largest international society of biomedical engineers. The organization’s 9,100 members reside in some 97 countries around the world. EMBS provides its members with access to the people, practices, information, ideas and opinions that are shaping one of the fastest growing fields in science24.

The IEEE EMBS was established as an organization in 1952 from a group of electronics engineers, members of the Institute of Radio Engineers (IRE), to consider “problems in biology and medicine which might be aided in solution by use of electronic engineering principles and devices”. Since then, the EMBS has grown into the largest international, member-based society of biomedical engineers and has made—through its meetings, publications and other activities—invaluable contributions to the advancement of biomedical and healthcare engineering”.

The mission of the IEEE EMBS is to: “advance medicine and biology through the application of engineering sciences and technology; promoting the profession of biomedical engineering, fostering professional development and recognizing excellence; presenting conferences that bring together scientists, engineers and physicians from multiple disciplines to disseminate knowledge and solve complex problems; establishing technical standards and providing global leadership for the profession”.

The fields of interests include “Diagnostic Systems (Conventional systems, Point-of-care diagnostics, Imaging and other tests), Therapeutic Systems (Neuromuscular devices, Cardiovascular devices, Cancer treatment, Drug delivery, Artificial tissues and organs), Healthcare and Bioinformation Systems (MIS, E-medicine, Distributed Diagnosis and Home Healthcare, Genomics,

24 Information extracted from: www.embs.org

INTRODUCTION proteomics, and physiome, Tools in drug discoveries), Technologies & Methodologies (Biosignal processing, Biomedical imaging, Medical instrumentation and sensors, MEMS and nanotechnology, Neural engineering, Rehabilitation engineering, Biorobotics, Biosystems modelling, Computational bioengineering and bioinformatics)”.

It is worth to mention that the EMBS has top journals in the field (like the IEEE Transaction on Biomedical Engineering and the Journal of Biomedical and Health Informatics) and that, recently the need for a new topic was identified and covered by the creation of the IEEE Journal of Translational Engineering in Health and Medicine (JTEHM): it is a journal that focuses on “innovative solutions to healthcare needs from the biomedical engineering, clinical engineering, and medical communities that bridge the engineering and clinical worlds” […] “The journal’s focus is interdisciplinary collaborations among researchers, healthcare providers, and industry” […] “Our ultimate goal is to improve the practice of engineering in translational medicine and to serve as a focal point for the nascent community”.

The Journal web page include also interactive material and editorial boards. For instance, during the IEEE EMBS Conference on Healthcare Innovations and Point- of-Care Technologies (HI-POCT), held in Seattle, Washington on October 2014. The conference brought together “the full spectrum of stakeholders who are involved in healthcare innovation and translational engineering, especially those who are focused on technological solutions that have a high potential to impact clinical practice. They discussed the critical issues and challenges faced worldwide in providing quality healthcare at an affordable cost and the use of innovative technologies for preventive, personalized and precision medical care in settings that range from the home to critical care facilities”.

The conference stimulated discussion toward developing a clear vision to promote healthcare innovation and greatly reduce the time-window of its translation from laboratory prototype to clinical application. It was also emphasized that there are certain global healthcare challenges that must be addressed to provide quality healthcare for all through major - or rather revolutionary – changes in industrial and political infrastructure support” […] “Though there were numerous challenges identified, from technology development to clinical deployment and acceptance by all stakeholders, the discussions concluded with a commitment to strong collaborative synergy for a brighter and healthier future”.

INTRODUCTION

Figure 20 – “Words Cloud” for Biomedical Engineers. The cloud has been generated from the most recurrent words of section 1.2.5.

1.2.5.3 In Summary Through the IFMBE and IEEE EMBS societies it could be possible to:

. access to recognized professional organisations that are focusing on the life cycle management of healthcare technology, . receive training about methods and tools that can support decision-making in health care at policy, clinician and management levels, . use tools that allow measuring the potential consequences not only of medical interventions but also of organizational interventions, . understand how to collaborate and establish better synergies with all stakeholders and inform decision-makers, in order to reduce the time- window of its translation from laboratory prototype to clinical application.

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1.2.6 Conclusions

Table 1 summarizes the conclusions of each subsection of section 1.2.

Table 1 - Summary of the main conclusions resulting from the multi-domain and multi-disciplinary analysis of existing solutions on tackling CDs

Characteristi . Efficient and cost-effective, cs that . providing information on outcomes to “activated modern citizens”. Models of . systemic and evidence-based, while pragmatic and affordable, Care need to . enabling synergies, new ways of working and new professional figures, incorporate. . providing early result research and continuous innovation, to inform decision makers and justify future investments, . stimulating system thinking, bottom-up integration, as well as positive and extra-sectorial “contaminations”, . reducing barriers between sectors and care providers, . systematically using information systems and . providing the context to enable innovation. Facts about . the Chronic Care Model and the related Innovative Care for Chronic existing Conditions Model are the most common frameworks for conceptualising models of effective components of care for people with long-term conditions. chronic care . There is limited high quality evidence about the impact of any model. . Few attempts systematically used Innovation to support and complement, rather than replicate and modify, the adoption of the Chronic Care Model in all this stages, dimensions and phases. . The CCM can be used as a reference model for enabling system thinking, but in the future new models could provide better evidence. Existing . Need for a translational and integrated approach initiatives . Support to longer, mid-term research and short term innovation. from the . Test and demonstrate new models and tools for health and care delivery Europe 2020 . Through the EIPonAHA and EIT on Health it could be possible to: strategy that  define and discuss healthcare innovations with all types of could stakeholders positively  assess their potential impact through the MAFEIP project impact  assess their maturity through the scaling up strategy chronic care.  transform Knowledge and Ideas into products and services  transform business ideas into market opportunities Reflections . Technologies and innovations have been influencing the way health care about the professionals have been interacting and working. role of . There is the need to continuously define new concepts, domains and eHealth in research areas. chronic care . It is important to understand the current healthcare context and its intersections with technologies and innovations. . Methods that help to represent and conceptualize healthcare context, are needed. . The eHealth paradigm, using “internal and external” methods, techniques and technologies, should help to 1) understand clinical knowledge, 2) represent and translate it, 3) properly communicate to all kind of stakeholders. Consideratio . There are recognized professional organisations that are focusing on the ns on the role life cycle management of healthcare technology, of . These organisations could provide knowledge about methods and tools to engineering support decision-making in health care at policy, clinician and management societies in levels, chronic care . There are tools that allow measuring the potential consequences not only of medical interventions but also of organizational interventions, . This would allow to collaborate and establish better synergies with all stakeholders, and reduce the time-window of translation of innovations from laboratory prototype to clinical practice.

INTRODUCTION

Figure 21 – “Words Cloud” of the conclusions of the background analysis. The cloud has been generated from the most recurrent words of section 1.2.6.

In this introductory chapter, the problem that the research work will try to address has been described (“improve the adoption of innovations from healthcare systems that are tackling the epidemics of chronic diseases”).

Then, a top-down, multi-domain, multi-disciplinary analysis of the problem has been carried out. The conclusions drawn from this analysis show that there are positive elements and factors that, if properly combined and embedded in the right instruments, will represent a solution to the problem.

2. RESEARCH HYPOTHESES AND OBJECTIVES

“La sapienza è figliola della sperienza.”

(Leonardo Da Vinci)

Based on the conclusions drawn in chapter 1, this chapter presents the hypotheses and the objectives of the research work.

RESEARCH HYPOTHESES AND OBJECTIVES

The following research hypotheses have been drafted:

Hypothesis 1: it is possible to define a translation process to convert a model of chronic care into a structured description of goals, requirements and key performance indicators.

Hypothesis 2: a translation process, if executed through evidence-based, multidisciplinary, holistic and business-oriented elements, can convert a model of chronic care in a descriptive framework, which defines the whole development cycle of innovative solutions for chronic disease management.

Hypothesis 3: it is possible to design a method to evaluate processes, outcomes and skill acquisition capacities, and assist multidisciplinary research teams in the creation of innovative solutions for chronic disease management.

Hypothesis 4: it is possible to assist the development of innovative solutions for chronic disease management through a reference framework and produce positive effects, measured through key performance indicators.

Main Hypothesis: it is possible to contribute to bridge the gap between healthcare and innovation and, in turn, improve the way chronic care is delivered by healthcare systems.

RESEARCH HYPOTHESES AND OBJECTIVES

The objectives are:

Objective 1: to define a Knowledge Translation Process to convert evidence based healthcare into actionable and structured knowledge, and assist healthcare stakeholders in the improvement of chronic disease management through innovation.

Objective 2: to develop a Descriptive Framework, as a new instrument that defines the design, implementation and evaluation development cycles of innovative solutions for chronic disease management.

Objective 3: to create a New Procedure to Evaluate Multidisciplinary Teams working in the definition of innovative solutions for chronic disease management.

Objective 4: to validate the Descriptive Framework and the New Procedure through a case study, to understand how they works and which results are generated, and finally deliver a Reference Framework.

Main Objective: to define a Systematic Approach for designing, implementing and assessing models of chronic care empowered by innovation and, in turn, assisting every type of healthcare professional in successful delivery of chronic care.

3. MATERIALS AND METHODS

“Ma per trovar il bene io ho provato Che bisogna proceder pel contrario: Cerca del male, e l'hai bell'e trovato; Però che 'l sommo bene e 'l sommo male S'appaion com'i polli di mercato”

(Galileo Galilei).

The methodological approach, organized in “Four Phases” that were executed to verify each one of the 4 hypothesis, is presented in the first part of Chapter 3. Then, the materials and methods, selected and executed throughout the 4 Phases, are described.

MATERIALS AND METHODS

Introduction to the methodological approach of the research

The methodological approach of this research work is composed of Phases that correspond to each one of the stated hypothesis.

In Figure 22, an overview of the entire process constituting the research work is represented: each hypothesis was related to a specific objective and phase, which delivered the corresponding result (vertical flow): the combination of hypotheses corresponds to the main hypothesis; the same applies between objectives and main objective, between phases and methodology, between results and the main result.

Figure 22 – Representation of the methodological approach of the research work.

Prior to the execution of these phases, in order to understand how to approach the problem, a multi-domain and multi-disciplinary analysis was carried out (“Phase 0”). This analysis, has been described in section 1.2 and was organized in 4 domains:

1. Healthcare initiatives in tackling chronic diseases. 2. R&D&I initiatives in the European Union related to chronic care. 3. The role of eHealth in Health and Social Care. 4. Existing international associations of Biomedical Engineering and their role in chronic care.

In all these analyses, particular attention was given to European based initiatives and facts (e.g. WHO European observatory, the EU H2020, the EIPonAHA,

MATERIALS AND METHODS evidence and applicability of models and methods in European Countries, etc.), in order to be able to properly test and assess the results of the research work.

In the following sub-sections, a description of the activities carried out in each phase is provided.

3.1.1 Phase 1

In order to define the Knowledge Translation Process (KTP), the JBI Joanna Briggs Institute (JBI) model of evidence-based healthcare was used (Pearson, 2005). This model depicts the four major components of the evidence-based healthcare (represented in Figure 23):

1. Healthcare evidence generation. 2. Evidence synthesis. 3. Evidence/knowledge transfer. 4. Evidence utilization.

Figure 23 - Representation of the Joanna Briggs Institute Model of evidence-based healthcare.

The four elements were further elaborated, in order to include transversal element, innovation, based on the conclusions drawn in chapter 1.

More in detail, the healthcare evidence generation component was further described to define the characteristics and conditions of a reference model of chronic care (based on the conclusions of section 1.2.1 and 1.2.2).

Then, given the definitions of eHealth (section 1.2.4):

. a commitment for networked, global thinking, to improve health care through ICT (Eysnback, 2001), . eHealth can act as a catalyst for innovation (Moen et al., 2012),

In order to add the innovative dimension, the definition of the evidence synthesis and evidence transfer components of the JBI model were further elaborated to define a domain translation (from healthcare to eHealth) and use eHealth to accelerate knowledge transfer.

In the evidence utilization component, elements that relates to the assessment of innovations have been formalized and defined (based on the conclusions of sections 1.2.3 and 1.2.5). This resulted in 4 Innovation Blocks (Figure 24) constituting the KTP, required to create a bridge between the healthcare and innovations.

MATERIALS AND METHODS

Figure 24 - the Innovation Blocks added to the JBI model of evidence-based healthcare.

3.1.2 Phase 2

The multi-domain and multi-disciplinary background analysis (section 1.2) provided an indication on the materials and methods to be used for the 4 Innovation Blocks, in order to translate the actual best available evidence into action (Figure 25).

Figure 25 - Materials and Methods selected to execute the KTP.

These methods and materials were used, combined, and when needed, adapted, to execute the KTP and obtain, as output, the descriptive component of the Framework that is a description of a model of chronic care in terms of goals, requirements and KPIs, and articulated in three development cycles (design, implementation and evaluation of the chronic care model).

Each step of the translation process was consolidated through the support of experts from the domains involved in each Innovative Block.

Then, the final output was presented to students and experts professionals of the healthcare sector (encompassing different disciplines like biomedical engineering, medical informatics and clinical engineering; public health, chronic disease management and medicine; innovation sectors; and policy makers), in order to test and improve its clarity, robustness, reliability, acceptance and usage by HC professionals.

3.1.3 Phase 3

Once the multi-disciplinary and multi-domain components were identified, and the feedback from the users of Phase 2 was analysed, a mixed-method to evaluate multidisciplinary teams working on innovations for chronic care, was created.

This method takes draw on concepts and techniques (outcome-based evaluation, process evaluation, and developmental evaluation) used in team science to evaluate multidisciplinary teams, as well as from HTA methods, which structure the assessment in the different dimensions that need to be analysed when an innovation is introduced in healthcare.

MATERIALS AND METHODS

This method adds a new element to the descriptive component of the Framework, which is a guidance (or procedural) dimension. The result of this phase consisted in a draft version of the framework, ready to be tested in a real scenario.

3.1.4 Phase 4

Once the process, the framework and the evaluation methods were defined, it was evident the need to identify a suitable experiment, to observe how the framework works.

The main research question of the case study was: which is the best way (how) to use the framework, and assist stakeholders in designing, implementing and evaluating innovative solutions for chronic care?

Given the nature of the research question (“how”?) and of the innovative elements of the 3 objectives, a participant observation case study was designed, to show and demonstrate how the framework is really supporting multidisciplinary teams in innovating to improve the management of chronic diseases.

A single and multilevel case study was selected, in order to have a complete but at the same time multi-sectorial evaluation of the framework.

The case study was evaluated through the procedural steps derived from phase 3 and through the different stages that were defined in the design of the case study.

The final stage of the case study is a report that discuss how the framework has worked and which are the changes and improvements that need to be applied. Therefore, the output of this phase is the Framework for enabling ChrONic care model uptakE (FICONE).

MATERIALS AND METHODS

Materials and Methods used for each Phase

Below, an overview of the materials and methods used for each phase is provided, while in the following subsections a detailed description is given.

. Phase “0”, multi-domain and multidisciplinary analysis.

 Institutional reports, literature, facts and news, related to care of CDs, divided in 4 domains

o Domain 1: how healthcare systems are tackling chronic diseases. o Domain 2: R&D&I initiatives in the European Union related to chronic care. o Domain 3: The role of eHealth in health and social care o Domain 4: The role of Engineering in chronic care.

. Phase 1, definition of the KTP:

 Results from Phase 0;  JBI Model of evidence-based Healthcare.

. Phase 2, definition of the descriptive component of the framework.

 Results from Phase 1;  Innovation Block 1, Model Description.

o The Chronic Care Model (CCM) (Wagner, 1996a). The CCM is “a synthesis of evidence-based system changes intended as a guide to quality improvement and disease management activities”. It is not a theory but a synthesis of the best available evidence instead. It is flexible to change and it has been produced involving a large group of advisers in its development. The main objective of the CCM is to create “practical, supportive, evidence based Productive Interactions between an informed and activated patient and a proactive and prepared care team”. o ARCHO Evaluation Instrument (Nuño, 2013a and 2013b). The ARCHO instrument (Assessment of Readiness for Chronicity in Health Care Organizations, in Spanish “IEMAC – Instrumento de Evaluación de modelos de Atención ante la Cronicidad”) is a tool for assessing the CCM, which was designed taking into account existing assessment tools and adapting them to European health care systems. The CCM, through ARCHO, is structured into 6 dimensions, 27 components and 80 interventions, turning it into a systemic instrument for supporting organizations pursuing integrated management of

MATERIALS AND METHODS

chronic diseases, encompassing public health, prevention, promotion, health care and coordination with social care;

 Innovation Block 2, Knowledge decomposition.

o Concept Maps (Novak & Musonda, 1991). Concept maps are diagrams that depicts suggested relationships between concepts. It is a graphical tool that designers, engineers, technical writers, and others use to organize and structure knowledge; o Problem Ontology Description (Sommerville, 2004). It is composed of abstract elements having three possible concrete types: Concept (category, an abstraction that shortens and summarizes a variety/multiplicity of objects by generalizing common identifiable properties), Predicate (assertions on concepts properties) and Actions (a change realized by an entity that modifies one or more properties of one or more concepts).

 Innovation Block 3, Requirement Elicitation.

o The CeHRes Roadmap (van Gemert-Pijnen et al., 2012). It is a development approach for eHealth interventions that, in order to create value-adding and sustainable eHealth technologies, incorporates both a human-centred design and a business modelling focus. Furthermore, the CeHRes roadmap places a strong emphasis on creating persuasive technologies. The roadmap consists of five phases (contextual inquiry, value specifications, design, operationalization and summative evaluation). Throughout the development process, formative evaluations are conducted in order to test design assumptions and prototypes.

 Innovation Block 4, Assessment.

o The Analytic Hierarchy Process (AHP). It is a method developed by Saaty (Saaty, 1977 and 1996) that provides a framework for structuring a decision problem, representing and quantifying its elements, and relating those elements to overall goals. Users of the AHP first decompose their decision problem into a hierarchy of more easily comprehended sub- problems. Once the hierarchy is built, the decision makers evaluate its elements by performing pairwise comparisons. o A Multidisciplinary requirement development approach (adapted from Van Velsen et al., 2013). It is a method for translating raw data into requirements, adapted from the CeHRes roadmap, was adopted. In this method, for each part

MATERIALS AND METHODS

of a transcript that is worthy of translation into a requirement, three derivatives are determined: values, attributes and requirements. o The Scaling-Up Strategy36 for the replication and transfer of (technological) innovations of the EIPonAHA. It is a guidance that present the steps for setting up an effective European scaling up Strategy, first describing “what to scale-up” and then “how to scale up”. o The MAFEIP tool (Boehler, 2014). In order to monitor the progress of the EIP on AHA initiative towards these objectives, the 'Monitoring and Assessment Framework for the EIPonAHA (MAFEIP) project' developed a web-based tool that allows estimating the change in quality adjusted life expectancy related to the activities carried out in the EIP on AHA and the estimated impact of a social or technological innovation on health and social care expenditure in a particular context.

 Consolidation of the Framework.

o Open ended questionnaires were delivered to healthcare stakeholders of the EIP on AHA, to discuss Part 1 - Design Cycle; o Iterative validation of Multidisciplinary Requirement (adapted from Van Velsen et al., 2013) was used to discuss Part 2 – Implementation Cycle, with experts of the IT Systems domain; o Document review was used to discuss Part 3 – Evaluation Cycle, with experts on HTA and Health Economy of the IFMBE and of the MAFEIP project. o The overall descriptive component of the framework was presented as an academic presentation, given to experts and non-experts in healthcare innovation during the 2nd IEEE EMBS Summer School on Emerging Technologies and Applications in Telemedicine25. After the presentation, a focus group debriefing session was held.

. Phase 3, definition of the procedural component of the framework.

 Results from Phase 2.  Mixed-methods for the evaluation of Multidisciplinary Translational Team (MTT) from Translational Health research (wooten et al., 2013).  Health Technology Assessment Core Model Handbook. A guide for people who conduct assessments and need to produce HTA information (Lampe et al., 2009).

. Phase 4, validation of the framework through a case study.

25 http://mhealth.sk/etat2/ accessed November 14, 2015

MATERIALS AND METHODS

 Results from Phase 2 and Phase 3.  Participant observation case study. Participant observation is the process enabling researchers to learn about the activities of the people under study in the natural setting through observing and participating in those activities. It provides the context for development of sampling guidelines and interview guides (DeWALT & DeWALT, 2002). It has been chosen as a method suitable to develop a holistic understanding of the phenomena under study that is as objective and accurate as possible given the limitations of the method.  Case Study. The activities started in METABO, a European funded research project (METABO, 2008), and continued till the present days, that the LifeStech research group has been doing, to define a new paradigm in the management of Diabetes Mellitus Type 1 and Type 2, have been selected as a single, multi-level case study.

3.2.1 “Phase 0”: background Analysis

The materials and methods used for the background analysis were:

. Domain 1: healthcare initiatives in tackling chronic diseases.

 Official policy reports on healthcare systems.  News and facts from key opinion leaders.  Literature Research on chronic care models and the related role of innovation.

. Domain 2: R&D&I initiatives in the European Union related to chronic care:

 Research: the Horizon 2020 framework programme.  Policy: the European Innovation Partnership on Active and Healthy Ageing initiative.  Business: the European Institute of Innovation and Technology for Health.  Literature research on the role of innovation in chronic care.

. Domain 3: The role of eHealth in Health and Social Care

 The work done by the European Federation of Medical Informatics on the definition of eHealth.  Literature Research on eHealth-related evidence.

. Domain 4: Existing international associations of Biomedical Engineering and their role in chronic care.

 The International Federation for Medical and Biological Engineering (IFMBE)  The IEEE Engineering in Medicine and Biology Society (EMBS).

MATERIALS AND METHODS

3.2.2 Phase 1: definition of the Knowledge Translation Process.

The JBI model of evidence-based healthcare is a developmental framework of evidence-based practice that “expands on the work of leaders in the field of evidence-based healthcare” (Pearson, 2005). It is based on 4 elements:

“

1. Healthcare evidence generation. Evidence may derive from different experiences, however, Pearson recognizes that “the results of well- designed research studies grounded in any methodological position are seen to be more credible as evidence than anecdotes or personal opinion”. When no research evidence of this level exists, other evidence may represent the “best available evidence” for a specific question. 2. Evidence synthesis. Evidence synthesis is the evaluation or analysis of research evidence and opinion on a specific topic to aid in decision making in healthcare. The increasing, ongoing interest and theoretical work on methods of synthesizing evidence from diverse sources are depicted as an element of evidence synthesis. 3. Evidence/knowledge transfer. This component of the model relates to the act of transferring evidence (knowledge) to individual health professionals, health facilities, and health systems, by identifying methods to package and transfer information that is understood and used in decision making. 4. Evidence utilization. This component of the model relates to the implementation of evidence into practice, as is evidenced by practice and/or system change. It identifies three elements: evaluating the impact of the utilization of evidence on the health system, the process of care and health outcomes; practice change; embedding evidence through system/organizational change.

” (Pearson, 2012).

3.2.3 Phase 2: creation of the Descriptive Component of the Framework.

The methods and the materials used to execute the KTP and derive the descriptive part of the framework are presented in detail, for each one of the four innovation blocks.

3.2.3.1 Block 1, Model Description In this block, the Chronic Care Model and the ARCHO instrument are presented. The first represent the best available evidence of models of chronic care, while the second represent the best available instrument that has further structured the CCM and assess how healthcare organisations are implementing a shift towards patient-centred care delivery.

MATERIALS AND METHODS

3.2.3.1.1 The Chronic Care Model (CCM) Starting from the work described on an important Cochrane Collaboration review, which highlighted the approaches (multifaceted), the components (provider-oriented, organizational changes, information system changes, patient-oriented interventions) and the interventions (the more comprehensive, the more successful) that were more effective in reducing complication prevalence and in improving health and disease-control outcomes (Renders et al., 2001), Dr. Ed Wagner and his group, director of the W.A. MacColl Institute for Healthcare Innovation at the Group Health Cooperative, recognized that the choice of these components had not been evaluated enough on a theoretical and empirical perspective: the findings were promising but research, validations and the definition of a practical model were recognized as needed (Wagner, 2001).

Dr. Ed Wagner leaded the development of a guide to chronic care improvement, the Chronic Care Model (CCM, copyrighted by the American College of Physicians) that is consistent in literature and useful to different organizational health care settings aiming at improve the care of patients with chronic illness.

Wagner group started from the assumption that chronic patients have a care practice team (led by different profiles and involving different providers, depending on the case) organizing and coordinating their care. Based on this assumption, the following objectives have to be reached (represented in Figure 26):

1. Productive interactions aim at improving patient outcomes “by 1) reviewing data related with patients’ perspectives and critical information about the management of the condition; 2) help patients to set goals and solve problems for improved self-management; 3) apply clinical and behavioural interventions; 4) ensure continuous follow-up” (Wagner, 2001). 2. The quality and productivity of providers/patient interactions is the key for determining good outcomes. 3. An empowered and active patient, combined with a care team that has the experience, the resources and the relevant information at point and time of need, are more likely to succeed.

MATERIALS AND METHODS

In order to reach the above objectives, the CCM defines six cluster areas of interventions, or dimensions26:

1. health care organization, 2. community resources, 3. self-management support, 4. delivery system design, 5. decision support, 6. clinical information systems.

Each area is further described in terms of detailed interventions. Some examples are provided below (excerpts taken from Wagner, 2005):

1. Health care organization:

 Support and promotion of the chronic disease improvement project by organization leaders is a predictor of success.  Leadership support is important for resources securing and barriers removal.  Linking chronic illness improvement with organization goals and business plan is a way to assure senior leaders’ involvement.  Approaches focused on goal-setting, rapid change cycles and measurement of goal achievements are more promising (Loring, 2000).

2. Community resources:

 Linkage with the community.  Access to community resources.  Patients should be encouraged to participate in effective community programs (e.g.: a good example of an effective program based in the community is the Chronic-Disease Self-Management Program developed at the University of Stanford (Loring et al., 2000)).  Organizations (especially the small ones) can benefit from services and resources (i.e.: nutrition counselling, peer-support groups) that are not available in their settings.

3. Self-management support:

 The main objective is to empower and prepare patients to manage their health by emphasizing the patient’s central role.  Including assessment, goals setting, and action planning, problem- solving and follow-up in practice routines through specific indicators.  Advice needs to be given carefully and linked to things that are important to patients.

26 The intervention areas are almost the same as the categories used by the Cochrane diabetes reveiew, but renamed in a different way.

MATERIALS AND METHODS

 Goals to be set up but focus given on those that are important to patients and breaking them down into smaller steps  Assistance with problem-solving.  This dimension is on the edge between the health system and the community: programs that support patients exist in the community.  The focus from traditional paternalistic education to encouragement and support to effective management is demanded.

4. Delivery system design.

 Teams should discuss the work they do and how to improve on it.  Interactions should be planned and be scheduled in the team members’ agenda.  Delivering high-quality care demands planning and actions coordinated between multiple care providers.  It is important to access to specialized clinical case manager functions like support for self-management skills and adjustment of treatment.  Group visits, are highly recommended.  Better outcomes in chronic illness care are due to proactive follow-up by the health care team.  Support for remote follow-up  Care should be personalized to patient’s needs, cultural background and in an understandable manner.

5. Decision support:

 The aim is to promote clinical care that is consistent with scientific evidence and patient preferences.  Guidelines should be get off the shelf, on a computer screen and be used, making it hard to do it wrong.  Good guidelines are stepwise described.  Closer collaboration and interaction between specialists, GP, nurses should be provided.  Patients may be informed about guidelines when this is pertinent to their care.  Guidelines are more effective when structured in patient care (e.g.: by integrating them into the registries, flow sheets, reminders and assessment tools).  Training methods, new relationships and increased communication with medical specialists ensure appropriate care for the more severely ill.

6. Clinical Information system

 The clinical information system should let organizing data in a way to facilitate efficient and effective care  Timely care reminders for providers and patients should be provided,

MATERIALS AND METHODS

 Patient subpopulations should be identified for proactive care  Print outs, care summaries, and communications from distant sites are all ways to increase the efficiency and quality of care.  Monitoring of practice through indicators embedded in the information system are valuable factors to assess system change.  The availability of electronic registries and the capability of using them to produce treatment planning reports is a critical step.

The CCM is not a theory but rather “a synthesis of evidence-based system changes intended as a guide to quality improvement and disease management activities” (Wagner et al, 1999). It is flexible to change and it has been produced involving a large group of advisers in its development (Bonomi et al., 2012). The model was then developed and expanded in different formats, like the "Care Model", "Planned Care Model", "Expanded Chronic Care Model" and the Innovative Care for Chronic Conditions (ICCC).

In the CCM (see Figure 27), the health system is seen as part of the larger community while the practice is part of the health organization: effective chronic disease management is provided by a well-organized delivery system linked with complementary community resources outside the organization and resulting in productive interactions between providers and patients.

Based on the lessons learned from validations of the chronic care model in different environments, the six elements where re-examined, but the relevance of the CCM as a reference for system change was confirmed in environments of different sizes and structures.

Figure 27. The Chronic Care Model (adapted from the image developed by The MacColl Institute, © ACP-ASIM Journals and Books, reprinted with permission from ACP-ASIM Journals and Books).

MATERIALS AND METHODS

3.2.3.1.2 The ARCHO Instrument, a tool for assessing the CCM. The Basque Country is an important region, from a HC system delivery viewpoint, as it was pioneer in implementing innovative programs, in having mid and long term strategies but actuated through short-term incremental steps, as it has been described in chapter 1.

They have created the O+Berri institution for managing and creating innovation. They are also linked and collaborate with the Miguel Hernandez de Elche private University, which has a specific master for Chronic Disease Management, build upon the CCM.

One of the most important results produced by this institution is the creation of the ARCHO (Assessment of Readiness for Chronicity in Health Care Organizations27) instrument (Nuño-Solinís, 2013a, 2013b).

This instrument was built on top of existing and validated assessment tools, like the ACIC (Assessment of Chronic Illness Care), developed by the same MacColl Institute (Bonomi et al., 2002) and the RAND Matrix (developed by the MacColl Institute together with researchers of Rand Health28, and of the Berkeley University), which were built in environments that are quite different from most of the European health systems.

A research expert group made a systematic review of papers published in Pubmed, between 2002 (when the ACIC was published) and 2010, of all the interventions and implementations of the CCM, as well as of all the indicators, evaluations and usage of the ACIC and RAND tools. These papers were analysed and used for the adaptation of the ACIC model.

After a first version, with 33 components and 256 interventions an iterative validation was done online by the same experts and led to a second version with 29 components and 106 interventions, ready to be validated.

The validation involved 18 professionals working in different aspect of the healthcare sector, in different regions of Spain that were assigned to three working groups and evaluated the structure, the clarity and pertinence of the interventions: this led to a third version of the ARCHO, included 6 dimension, 27 components and 80 interventions.

Then, a second group of 60 professionals performed a new validation and examples of interventions were added. A third group of 28 experts brought field experiences to the model.

The ARCHO 1.0 is thus composed of 6 dimension, 27 components and 80 interventions, keeping a strong relationship with the structures of the RAND and ACIC tools, but not being the result of an automatic translation.

27 in Spanish “IEMAC – Instrumento de Evaluación de modelos de Atención ante la Cronicidad” 28 Main findings available at http://www.rand.org/health/projects/icice/findings.html accessed November 14, 2015.

MATERIALS AND METHODS

ARCHO is a systemic instrument for supporting organizations pursuing integrated management of chronic diseases, encompassing public health, prevention, promotion, health care and coordination with social care.

The development of this instrument was inspired by the following principles (Figure 28):

“

. A systemic approach to chronic conditions that considers the organisation holistically and underscores the synergistic value of interventions; . the use of evidence-based interventions, whenever possible; . a drive for continuous improvement and innovation to ensure progress in the management of chronic conditions.

” (Nuño et al, 2013a).

Figure 28 – The 3 principles that inspired the development of the ARCHO instrument: evidence based, systemic approach, continuous improvement and innovation (adapted from (Nuño-Solinís, 2013a, 2013b).

It is for this reason that the ARCHO instrument has been selected in this research work to further structure the description of the CCM.

The ARCHO is delivered as an online questionnaire and can be used as a self- assessment tool “in a variety of contexts and across a range of organisational levels. Specifically, it can be used at all decision-making levels: macro, meso and micro; and in all healthcare levels”.

Nevertheless, depending on the level, the relevance of some dimensions can vary. Dimension 1 Organisation of the Health System, is more meaningful at

MATERIALS AND METHODS macro levels; Interventions of the Dimension 4, Self-Management, are more relevant at the micro levels. Interventions in Dimension 3, Health Care Model, are particularly applicable at the meso level. On the other hand, the ARCHO offers the opportunity to integrate assessments from the macro, meso and micro levels in order to build up an overall picture of the system.

As regards the assessment, it is suggested that this is carried out by a group of professionals with different profiles and management responsibilities within the organisation and, for some interventions, to include the perspective of patients too.

When performing the assessment, it is recommended to answer to questions according to the following order:

. For the macro level: assessing Dimensions 1, 2, 3, 4, 5 and 6. . For the meso and micro levels: Dimensions 3, 4, 2, 1, 5 and 6.

Figure 29 – Structure of the ARCHO instrument. For each one of the six ‘Elements’ of the Chronic Care Model, each dimension is organized in ‘Components’ and ‘Interventions’. (adapted from Nuño-Solinís, 2013a and 2013b).

The questionnaire consists of six dimensions, related to the six elements of the Chronic Care Model. As illustrated in Figure 29, each dimension is structured into a list of components (n=27), and each component into a set of interventions (n=80):

For each dimension and component, a number of statements are proposed (corresponding to possible interventions). Each of these must be rated, on a scale of 0 to 100, reflecting the current situation in the health organisation being assessed. Each score should be accompanied by a description of the specific measures in place or actions carried out that justify the rating, in order to provide evidence to support the assessment. As regards the frequency of assessment, it is recommended to start with an annual self-assessment and to lengthen this interval depending on the levels achieved and the number, intensity and type of improvement interventions undertaken”.

MATERIALS AND METHODS

The tables below provide a description of the components of each one of the 6 dimensions of the CCM. A complete description of all the components and interventions is provided in ANNEX 129.

Table 2 – Components of the CCM Dimension 1, as defined by the ARCHO instrument.

ORGANISATION OF THE HEALTH SYSTEM This dimension deals with the transformation of the health system with the aim of improving population health through a shared vision. It is based on adequate funding schemes, information systems that allow for evaluation, improvement and innovation, and the alignment of social and health policies. Leadership commitment Strategic framework Population-based approach Information system, evaluation, improvement and innovation Funding scheme Social and healthcare policies

Table 3 - Components of the CCM Dimension 2, as defined by the ARCHO instrument.

COMMUNITY HEALTH This dimension refers to cooperation between the healthcare system and community resources, organisations and institutions in the prevention and management of chronic conditions. Community strategies in health plans Alliances with community stakeholders Linking patients to community resources

Table 4 - Components of the CCM Dimension 3, as defined by the ARCHO instrument.

HEALTHCARE MODEL This dimension refers to how to advance towards proactive models of care which address the needs of each patient in a comprehensive way and in which the different departments/units and professionals involved carry out their functions in a planned, structured and coordinated manner. Patient-centred care Professional competencies related to chronic care Multidisciplinary teamwork Integration and continuity of care Active patient follow-up Innovation in interactions between patients and healthcare professionals Clinical management of chronic conditions and incentive schemes

29 The ARCHO instrument has been downloaded from www.iemac.org.

MATERIALS AND METHODS

Table 5 - Components of the CCM Dimension 4, as defined by the ARCHO instrument.

SELF MANAGEMENT This dimension refers to the involvement of patients in their own care and the management of their condition. It requires the effective use of support and training strategies to ensure that patients have the necessary motivation, knowledge, skills and resources*. * 4. Active patients who have productive relationships with their medical teams are pivotal in the new models of management of chronic conditions Patient assessment for self-management Structured therapeutic education Psycho-social development of patients and mutual support Tools to facilitate self-management Shared decision-making

Table 6 - Components of the CCM Dimension 5, as defined by the ARCHO instrument.

CLINICAL DECISION SUPPORT This dimension refers to the capacity of the system to improve health outcomes using decision support tools, training of professionals and exchange of knowledge among providers of care to chronic patients. Protocols and shared guidelines Continued education and training Liaison and consultation

Table 7 - Components of the CCM Dimension 6, as defined by the ARCHO instrument.

INFORMATION SYSTEMS This dimension refers to the use of information to support clinical and population management, distributing relevant information in a structured, proactive and integrated manner between the various information subsystems, to improve care for chronic patients. Information for management and clinical practice Integration of patient clinical data Reporting of clinical information between professionals

MATERIALS AND METHODS

3.2.3.2 Block 2, Knowledge decomposition. In this block, existing materials and methods useful to synthesise the “medical” elements (i.e.: dimension, components, interventions) in such a way that these elements can be analysed from another perspective (i.e.: eHealth), have been selected.

A knowledge decomposition of the medical elements into atomic elements that are the primitive elements of the 2nd domain, took place, through the adoption of concept maps and the taxonomy of problem ontology description.

3.2.3.2.1 Concept Maps Concept maps are graphical tools for organizing and representing knowledge.

Concept maps were developed in 1972 in the course of Novak’s research program at Cornell, out of the necessity to find a better way to represent children’s conceptual understanding (Novak & Musonda, 1991). The program was based on Ausubel’s learning psychology (Ausubel et al 1963; 1968; 1978), were “learning takes place by the assimilation of new concepts and propositions into existing concept and propositional frameworks held by the learner”:

. First concepts “are acquired by children during the ages of birth to three years, when they starts to recognize regularities identify labels or symbols for these regularities” (Macnamara, 1982). This is known as a discovery learning process. . After age 3, a reception learning process takes place, during which meanings are obtained by asking questions and getting clarification of relationships between old concepts and propositions and new concepts and propositions. . Additionally, there is the meaningful learning process, which requires three conditions:

1. The material to be learned must be conceptually clear and presented with language and examples relatable to the learner’s prior knowledge. 2. The learner must possess relevant prior knowledge. 3. The learner must choose to learn meaningfully.

. If a rudimentary conceptual understanding of the phenomenon a learner is investigating is missing, little or no gain in the relevant knowledge will be achieved.

According to the Florida Institute for Human & Machine Cognition30:

. a concept is a perceived regularity in objects designated by a label”. . Propositions are “statements about some object in the universe, either naturally occurring or constructed.

30 http://cmap.ihmc.us/docs/theory-of-concept-maps

MATERIALS AND METHODS

. Propositions contain two or more concepts connected using linking words or phrases to form a meaningful statement, sometimes called semantic units, or units of meaning. . A final feature that may be added to concept maps is specific examples of objects that help to clarify the meaning of a given concept.

Figure 30 shows an example of a concept map that describes the structure of concept maps and illustrates the above characteristics.

Figure 30 - A concept map showing the key features of concept maps. Concept maps tend to be read progressing from the top downward (source: http://cmap.ihmc.us/docs/theory-of-concept- maps).

Interesting instructions on how to construct good maps are provided by the Florida Institute, these are:

“

. it is important to begin with a domain of knowledge that is very familiar to the person constructing the map. . it is best to identify a particular problem or question that one is trying to understand. . This creates a context that will help to determine the hierarchical structure of the concept map. . It is helpful to select a limited domain of knowledge for the first concept maps. . A good way to define the context for a concept map is to construct a Focus Question, that is, a question that clearly specifies the problem or issue the concept map should help to resolve. . Every concept map responds to a focus question, and a good focus question can lead to a much richer concept map.

MATERIALS AND METHODS

. Given a selected domain and a defined question or problem in this domain, the next step is to identify the key concepts that apply to this domain. . The next step is to construct a preliminary concept map. . This can be done by writing all of the concepts on Post-its(TM), or preferably by using the IHMC CmapTools (Cañas et al., 2004b, http://cmap.ihmc.us) computer software program. . It is important to recognize that a concept map is never finished. After a preliminary map is constructed, it is always necessary to revise this map. . Other concepts can be added. Good maps usually result from three to many revisions. This is one reason why using computer software is helpful ”. The IHMC Cmap Tools was used in this research work.

MATERIALS AND METHODS

3.2.3.2.2 Problem Ontology Description The main goal of a Domain Ontology Description is to give an overview about an application’s context, in which stakeholders naturally express requirements in their own terms and with implicit knowledge of their own work (Sommerville, 2004). For a given input, the problem’s ontology is deduced from a set of text descriptions of the system usage scenarios, from interviews of stakeholders and “experts” of the domain, and from the previously identified requirements. As output, the ontology is described in terms of concepts, predicates, actions and their relationships.

The Agent-Oriented Software Process for Engineering Complex Systems (ASPECS) defines an UML profile to describe an ontology. The main elements are described in Table 8.

Table 8 - Definition of the problem domain concept, by mapping ASPECS meta-model and UML constructs (extracted from http://www.aspecs.org/Home).

Ontology An explicit specification of a conceptualization of a knowledge domain. An ontology is composed of abstract ontology elements having three possible concrete types: Concept, Predicate or Action. Concept A category, an abstraction that shortens and summarizes a variety/multiplicity of objects by generalizing common identifiable properties. Predicate Assertions on concepts properties. Action A change realized by an entity that modifies one or more properties of one or more concepts. Organization An organization is defined by a collection of roles that take part in systematic institutionalized patterns of interactions with other roles in a common context. This context consists in shared knowledge and social rules/norms, social feelings, etc. and is defined according to an ontology. The aim of an organization is to fulfil some requirements. Role An expected behaviour and a set of rights and obligations in the organization context. The goal of each Role is to contribute to the fulfilment of (a part of) the requirements of the organization within which it is defined. Interaction A dynamic, not a priori known sequence of exchanged among roles, or between roles and entities outside the agent system to be designed. Capacity A specification of a transformation of a part of the designed system or its environment. Role Task An activity that defines a part of a role behaviour. A Role Task may be atomic or composed by a coordinated sequence of subordinate Role Tasks. Role plan The behaviour of a Role is specified within a Role plan. It is the description of how to combine and order Role Tasks and interactions to fulfil a (part of a) requirement. Scenario Describes a sequence of role interactions which a (part of) requirement.

MATERIALS AND METHODS

3.2.3.3 Block 3, Requirement Elicitation: the CeHRes Roadmap. In 2011, the Group from the University of Twente, published in an article called “A Holistic Framework to Improve the Uptake and Impact of eHealth Technologies”, the CeHRes Roadmap (van Gemert-Pijnen, 2011). This roadmap was built as a result of a systematic review of existing eHealth frameworks, through which the authors gathered the most successful strategies and principles and at the same time, tried to overcome the limitations found. This framework is modular, it is based on a participatory development approach, persuasive design techniques and business modelling and serves as an evidence-based roadmap (van Velsem et al., 2012; van Limburg., 2011): it is thus suitable for the research work purposes and can be used to structure the different activities (research, development, business modelling, validation and evaluation) in a unified strategy.

Figure 31 – Representation of the phases of CeHRes Roadmap (adapted from: http://www.ehealthresearchcenter.org/wiki/).

As represented in Figure 31, the CeHRes Roadmap consists of five phases (from the CeHRes wiki) and one iterative retrofitting phase:

. “Contextual Inquiry: in this phase, the design team must get an understanding of prospective users and their context, and analyse the strong and weak points of the current provision of care. . Value Specification: then, one must determine which values the different stakeholders deem important. These values and prospective users’ needs and wishes need to be translated into user requirements. . Design: Based on the requirements, (a prototypical version of) the technology can be developed. The roadmap advocates the application of cooperative design in which the design team creates the technology with prospective users and stakeholders together. . Operationalization: Now, the technology is launched, marketing plans are set into motion, and organizational working procedures are put into practice. . Summative Evaluation: finally, the eHealth technology is evaluated: How is it being used and what is its effect on patients and healthcare? . Furthermore, the products created in each phase should be the subject of Formative Evaluation, aimed at gathering input for improving the product.”

MATERIALS AND METHODS

For each phase, the CeHRes Roadmap provide guidance in terms of main research questions, tasks and methods, as represented in Table 9.

Table 9 - Overview of the research questions, tasks and methods suggested in the phases of the CeHReS roadmaps ( extracted from the CeHRes wiki.)

CeHRes Phase Research questions Tasks Research Methods Contextual Inquiry . What is the healthcare problem? . Discuss the problem Not defined for this phase . Who has a stake in addressing the problem? . Stakeholder Analysis Value . What improvements in the quality of care are desired by . Identify key stakeholders . Focus groups Specifications the stakeholders? . Key stakeholders rank the values . Business Model Canvas . How can technology contribute to better quality of care? . Stakeholders discuss in what modalities . Critical Decision system software . In what manifestation can technology contribute? can contribute . Attribution chain software . Stakeholders discuss requirements . Value-chain software Design . Does the design of the eHealth technology meet the . Test the design among experts (designers, . Cognitive walkthrough stakeholder requirements? technicians, researchers) . Persuasive design . Test the design among the user target . Prototyping group . Usability testing . Evaluation criteria: system, content and . Scenarios & tools. service quality Operationalization Not defined for this phase. Not defined for this phase Not defined for this phase

Summative . Assessing uptake Measure Impact Indicators assessing Not defined for this phase. Evaluation . How is the eHt being used over a sustained period of . the uptake of the intervention time? . health care delivery . Who is motivated and capable to use it? . impact on patient health & well-being . What reasons explain the usage behaviour? . Assessing impact: . What impact has the eHt upon health care delivery? . What impact has the eHt upon patient health & wellbeing? Formative . Has the goal of the phase been reached? Not defined for this phase. . Focus Groups Evaluations. . Observations . cognitive walkthrough . usability test . heuristic evaluation

MATERIALS AND METHODS

3.2.3.4 Block 4, Assessment.

3.2.3.4.1 The Analytic Hierarchy Process (AHP). The AHP is a method developed by Saaty, “which provides a framework for structuring a decision problem, representing and quantifying its elements, and relating those elements to overall goals” (Saaty, 1977 and 1996).

Users of the AHP first decompose their decision problem into a hierarchy of more easily comprehended sub-problems. Once the hierarchy is built, the decision makers evaluate its elements by performing pairwise comparisons. Moreover, it is possible to assess the coherence of respondent judgments and ask the experts to refine incoherent answers. Once judgements are finalized, it is possible to extract:

. the relative importance of each need per category (local weights, LW), . the relative importance of each category (category weights, CW), . the importance of each need compared to all the others (Global weights, GW).

In healthcare research, the AHP has proven to be effective in a variety of applications (Danner et al., 2011), like medical diagnosis, for increasing patient participation, selecting therapies and treatment, medical decision-making and in user requirements and human resource planning. There have been numerous applications for selection and evaluation of projects and technological innovations in health care settings, and also for medical technology assessment that occurs during the development process and prior to clinical diffusions, as well as for the evaluation of health care facilities and in health care policy analysis. An increased interest in its application for evaluating health care facilities has been also noted (Liberatore and Nydick, 2008), demonstrating the AHPs ability to facilitate understanding of the underlying criteria and priorities, and to successfully support the decision support for HTA projects.

In fact, this method has been recently included by the HTA Division of the IFMBE among the techniques to be used by biomedical engineers in early stage assessment of medical innovations (training was given during a Summer School on Health Technology Assessment, organized under the umbrella of the IF31MBE, on 8th-10th September 2015, University of Warwick.Coventry, United Kingdom).

In this research work AHP was used to elicit user needs and rank them through questionnaires, that were delivered through the Business Performance Management Singapore (BPMS) project, a non-commercial website32, where information is shared for educational purposes, and tools for business management are provided.

31 http://www2.warwick.ac.uk/fac/sci/eng/research/systems/abspie/hta/: accessed on November 2015. 32 http://bpmsg.com/

MATERIALS AND METHODS

Among them there is the AHP-OS33 software implementation, realized in PHP, using OOP (object oriented programming), running on a Linux server (Goepel, 2013).

3.2.3.4.2 Translating the elicited requirements in written, categorized and measurable specifications. Once requirements elicitation sessions are completed, their output needs to be translated into requirements. “This step often remains unmentioned in requirements engineering reports, and methodological explanations of this step are scarce” (van Velsen et al., 2013). A method for translating raw data into requirements, adapted from the CeHRes roadmap, (van Velsen et al., 2013), and based on (Bergvall-Kåreborn et al., 2010; Mullhall, 2003), was adopted. In this method, for each part of a transcript that is worthy of translation into a requirement, three derivatives are determined: values, attributes and requirements. These derivatives are defined in the CeHRes roadmap:

. “Value is an ideal or interest a (future) end-user or stakeholder aspires to or has. . Attribute is a summary of the need or wish that is spoken out by the (future) end user or stakeholder. . Requirement is a technical translation of an attribute.”

Each derivative can be used to communicate about the innovation with a specific group of people (technologists understand requirements, marketing departments use attributes, and policy makers prefer values). Furthermore, attributes and values can be used to group requirements, which makes it easier to set priorities later on.

To aid the translation process, the analyst can complete a translation table. The following steps are taken to ensure a reliable translation of data into requirements.

1. The analyst familiarizes him or herself with the data. 2. Quotes that capture something important in relation to the overall goal(s) of the eHealth technology are identified and listed in the “user expression” column. 3. For each quote, the attribute or attributes are determined. An attribute should be formulated as a very short summary of the end user or stakeholder expression. 4. Quotes are grouped on an attribute level. Quotes that can be transformed into the same attribute are merged in one row. 5. The analyst checks all quotes and the attributes that flow from them, and determines whether the attributes are correct and distinctive. If necessary, attributes are adjusted.

33 http://bpmsg.com/academic/ahp.php

MATERIALS AND METHODS

6. Per attribute, one or more requirements are formulated. They specify the end user or stakeholder expression into terms a system designer can work with. Requirements should be formulated as precisely as possible, and usually are sentences like ‘The system must…’ 7. An independent analyst checks the attributes and requirements formulated. He or she notes disagreements or suggestions. Then, the initial and second analyst discuss these findings. 8. Attributes and requirements are adjusted based on the discussion between the first and second analyst. 9. The first and second analyst determine the values together. Most often, there are only a few values that are linked to many attributes. Values should be formulated in a few words.

At this point, the project team will have a list of specified requirements, or specifications, derived from elicitation activities. Each requirement can be documented in such a way that it enables the responsible developer to understand what needs to be made and why. The requirements documentation serve also as starting point for evaluations.

There are different kinds of specifications that need to be shared with different kinds of people that are involved in the creation of the solution. The following definitions have been used:

. Behavioural Specifications: these are requirements that specify the action to be taken and the elements that need to converge for the behaviour to occur. . Value Specifications: based on the first two of the three derivatives defined in the CeHRes Value Specification Phase, values and attributes34 are specified. This way, attributes are communicated, analysed and verified as user needs. For each value/attribute, the type of user need is determined:

 Service requirements, specifying how services need to be organized. Mostly meant for managers, responsible for these services.  Organizational requirements, specifying how the need should be integrated in the organizational structure and working routines. Mostly meant for managers of the organizations in which the need is to be implemented.

. System Specifications, categorized according to the following criteria:

 Functional and modality requirements, specifying technical features and on what kind of technology (e.g. tablet, smartphone or desktop

34 According to the CEHRES Roadmap: “a Value is an ideal or interest a (future) end user or stakeholder aspires to or has; an Attribute is a summary of the need or wish that is spoken out by the (future) end user or stakeholder; a Requirement is a technical translation of an attribute”.

MATERIALS AND METHODS

PC) and operating systems the technology should work. Mostly meant for programmers.  Service requirements, specifying how services surrounding the technology, like marketing or user support, need to be organized. Mostly meant for managers, responsible for these services.  Organizational requirements, specifying how the technology should be integrated in the organizational structure and working routines. Mostly meant for managers of the organizations in which the technology is to be used.  Content requirements, specifying the content that needs to be communicated via the technology and, if applicable, language level, persuasive approach, and special accessibility demands. Mostly meant for content managers.  Usability & User experience requirements, specifying the interface and interaction design of the technology and how user experience factors, such as trust or fun, should be integrated into the technology. Mostly meant for human factors specialists.

MATERIALS AND METHODS

3.2.3.4.3 Verifying the design and the implementation of requirements Requirements are a translation of end users’ and stakeholders’ needs and wishes into design, and should therefore be checked.

Fit criteria are measures of success for this translation and are the basis of evaluations.

Often, functional requirements cannot be evaluated with users as they are simply implemented or not (like a requirement specifying that type of data x is collected from database y). In this case, formulating a fit criterion is useless.

In the other cases, whether or not a fit criterion is formulated or not depends on its priority (when there is no possibility to evaluate all requirements, only those with a high priority, or controversial requirements should be evaluated),

What follows is a description the main methods used: these methods were selected from the formative evaluations, the design and value specification phase of the CeHRes roadmap. In addition, a method to design and verify behaviours has been included, taking inspiration from the extra sectorial contamination suggested in the background section:

. The Fogg Behavioural Model to define and verify behavioural specifications. The Fogg Behaviour Model (FBM) is based on a behavioural model created by B.J. Fogg in 2009 (Fogg, 2009). According to the FBM, “three elements must converge at the same moment for a behaviour to occur (Figure 32):

1. Motivation 2. Ability 3. Trigger

When a behaviour does not occur, at least one of those three elements is missing. Triggers that occur when a person is above the ability threshold (Figure 32) are likely to be met with action. The FBM highlights three principal elements35, each of which has subcomponents. Specifically, the FBM outlines three Core Motivators (Motivation), six Simplicity Factors (Ability), and three type of Triggers.

35 for more information, see www.BehaviorModel.org

MATERIALS AND METHODS

Figure 32 - The FBM factors needed for a behaviour to occur (source: the FBM, by Dr. BJ Fogg, Stanford University).

For example, in the FBM the word Ability refers to the how the six Simplicity Factors work together in the context of a Trigger. To succeed in designing a behaviour, one need to understand the type of behaviour to seek”. A behaviour grids further categories different type of behaviours, as described in Figure 33.

Figure 33 – the Fogg Behaviour Grid (source: The Behaviour Grid, by Dr. BJ Fogg, Stanford University).

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Some target behaviours are one‐time actions, while others happen every day (e.g. exercising, eating), yet others consists of terminating a bad routine (e.g. smoking tobacco). Using the Fogg Behaviour Model as a guide, “designers can better understand why a person performs a given behaviour. For example, if people are performing an undesired behaviour, such as smoking a cigarette, the FBM can help designers identify ways to reduce or stop the behaviour”. For each behaviour of the FBG, a Path Behaviour Guide has been created by Fogg, describing the elements that are needed to design and verify if motivations, triggers and ability factors are in place (Figure 33). . Methods to define and verify value specifications

 Observations can be especially useful for understanding actual end user behaviour and their social, physical and spatial surroundings (Mulhall, 2003). As a result, they also provide the option to see what tacit knowledge drives end users. Observations can be used to elicit requirements that specify the functions and modality of the eHealth technology (Mays, 1995).  Interviews may be used to uncover end users’ or stakeholders’ behaviour or opinions, their motivations or rationale for these, and their wishes regarding the to-be-developed technology. They are also well-suited for collecting data upon which personas can be based (Lerouge, 2011). Personas are fictitious users whose characteristics resemble the average for an end user (segment) and who is presented in a biography with a photo (Cooper, 1999). Personas are well suited in this context, as they are easy to understand for the wide variety of stakeholders involved in eHealth design. They can then be used to spark the discussion among stakeholders during a focus group or can serve as input for content requirements. Interviews should be used to profile end users and stakeholders, and to elicit requirements that will specify functions, content, and the user experience (or more information on how to conduct a requirements elicitation interview, refer to Sutcliffe, 2002).  Focus groups can be used for establishing the context, roles and primary tasks that are or could be supported by technology with stakeholders, and what business model should support this. Via personas, scenarios and task demonstrations, stakeholders can gain insight into, and reach consensus on the context, the division of roles, the scope of the eHealth technology, and the flow of funds, requirements, and requirement priority. Focus groups can also serve to explore the context and need of a new activity or work practice that involves eHealth, to learn how this could be designed and introduced into current work patterns or daily activities (Wentzel, 2012). Again, personas and scenarios may be used to elicit ideas on the new activity. In short, focus groups are very well suited to elicit input for

MATERIALS AND METHODS

implementation strategies and business models (for instructions on how to conduct focus groups, refer to Morgan, 1997).

. Methods to define and verify system specifications

 Usability heuristics, guidelines and standardized design methodology are used in order to identify usability issues in the existing concepts or prototypes of the respective module. As a result, the concept or prototype is refined. It is performed by usability professionals, using heuristics. Usability heuristics are something similar to design guidelines, giving descriptions of how an interface should look like (see ISO 62366; Nielsen, 2010). Nielsen says it all: an independent usability professional can save a lot of time and resources by correcting obvious mistakes before performing a user test, which is more expensive and cumbersome. The disadvantage of this method is that it does not identify all possible problems. This is not an issue, as a usability test can be planned to cope with the remaining problems. Heuristics like DIN EN ISO 9241-110 (2006) – Dialogue principles (ISO, 2006) and Jakob Nielsen’s ten usability heuristics (Nielsen, 2005) can be used.  Cognitive walkthrough. This is another usability inspection methods but, differently from the heuristic analysis, which takes a holistic view to catch problems, it is task-specific, focusing on how easy it is for new users to perform the desired tasks.  Usability Tests. This testing by users would be the final step in the usability engineering. Users would complete pre-defined test tasks. Their behaviour would be recorded and their satisfaction measured with questionnaires. Thus, it would be possible to identify final potential for the improvement of the software prototypes. Usability Testing can serve two purposes: the first would be to determine, which of two prototypes has a higher usability (“comparative testing”), the second would be to determine the usability of one prototype and to find ways to improve it (“formative testing”). In healthcare innovations, different tools are being developed for different user groups which are characterized by distinct user requirements. Therefore, the latter (“formative”) approach will be applied. According to DIN EN ISO 9241 (ISO, 1997), usability is “the extent to which a product can be used by specified users to achieve specified goals with effectiveness, efficiency and satisfaction in a specified context of use.” Usability can be measured, according to this standard:

o Efficacy is the extent to which the user is able to achieve the respective goal(s). Hence, efficacy is a relative measure, ranging from 0% to 100%. A common operationalization of efficacy is the percentage of tasks completed successfully by the user.

MATERIALS AND METHODS

o Efficiency is the efficacy of the user, divided by the amount of resources the user needs to spend in order to reach this efficacy. The primary resource is time but force, concentration and “annoyment” can also be important factors. A common measure of efficiency would therefore be the time to complete each task. o Satisfaction is the user’s “subjective reaction” to the interaction with the product (ISO 9241). According to Hassenzahl (2004), user satisfaction is an emotion which results from the user comparing his expectations of the system to his actual experiences with it. Satisfaction can therefore only be measured by asking the user about his feelings towards the system. When measuring efficacy and efficiency, a desired value cannot be deducted by theory. As long as there is not any alternative system for comparisons, the definition of a desired minimum level is up to the experimenters. With respect to the efficacy, it would be possible to define, a priori, tasks that must be completed by a) all users or b) a majority of users, and other tasks that are rather facultative. With respect to efficiency, thresholds of time or number of errors can be defined a priori, which should not be trespassed by a) any user or b) the majority of users. In the case of user satisfaction, standardised questionnaires can be used. However, the idea of standardisation comes from types of questionnaires that are applied in similar contexts and concerning similar objects. Standardised questionnaires are the best we can get, however, the standardisation does not have the same relevance as e.g. in the case of personality questionnaires. Due to the possible biases caused by the acquiescence tendency and the effect of socially desired answering (for both, see Amelang & Zielinksi, 2002), the entire sample’s mean value of satisfaction should be above the middle of the scale.

3.2.3.4.4 The Scaling-Up Strategy for the replication and transfer of (technological) innovations of the EIP on AHA In the Scaling up strategy36, issued on early 2015 an approach on how to ensure implementation of innovative solutions for active and health ageing was presented. The approach focusses on two key elements:

1. What to scale up. It includes identifying practices, projects and innovations to be scaled up; the EIP on AHA is currently defining a Repository of innovative practices for the EIPAHA and beyond, which can be extensible and scalable. The templates used for this collection are based on the following taxonomy:

36 https://ec.europa.eu/research/innovation-union/pdf/active-healthy- ageing/scaling_up_strategy.pdf

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. Description of the practice: methodology, process (how it was done), timing, target population, objectives, funding. . Innovation: key innovative elements and ways of overcoming barriers to innovation. . Impact/results: evidence on the coverage, health benefits, system’s improved efficiency. . Formal or informal evaluation/added value. . Success criteria used to determine whether the initiative is working well. . Transferability aspects for other organisations / regions. . Lessons learnt and recommendations for others. 2. How to scale up. The how focusses on the methods of going to scale. An independent Expert Panel (De Maeseneer, 2015), setup by the EC, proposed an assessment framework comprising “an evaluation of: impact on common values, impact on outcomes, and a feasibility study, all analysed within a specific contextual frame (see Figure 34). There are also other examples of assessment frameworks that relate to specific types of innovation. For example, assessment tools have been developed by WHO-Europe together with the Healthy Cities Network in the area of age-friendly environments. Based on WHO/ExpandNet work, and the Partnership’s work on the good practices catalogue and Reference Sites ‘How to guide’, the following framework for implementation of individual scaling-up is proposed: . Planning the innovative service & setting up a system for change: research findings show it is necessary for the interested organisations to do first a preliminary assessment of the context. Transfers of innovation is facilitate if:

 The real needs that the innovation will serve are identified and a strategic implementation plan is consequently defined.  Committed leadership from central and local authorities is present  Multi-sectorial stakeholders’ alliances, ecosystems, multidisciplinary teams, new relationships, agreements, bottom-up initiatives, “narratives beyond cost containment” are present.  Missing arrangements for reimbursement of the service and definition of business model are significant barriers to large scale deployment.  Financial support (e.g.: dedicated budget, standardization of procurement, fund-raising organizations) is secured

. Organisational process and design choices:

 Education of care professionals and citizens is essential (jet: national/regional/local training strategy, redesign or definition of new roles  Technical support and troubleshooting  Service re-design and organizational changes

. Monitoring, evaluation and dissemination. Key elements of this phase are:

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 Assessment indicators  Mutual learning  Dissemination activities  Scaling-up of the new GP

Figure 34 - Elements for selection and prioritisation of policies/interventions. (Adapted from De Maeseneer, 2015).

3.2.3.4.5 The MAFEIP tool. In order to monitor the progress of the EIP on AHA initiative towards these objectives, the 'Monitoring and Assessment Framework for the EIP on AHA (MAFEIP) project' was launched jointly by the European Commissions' (EC) Joint Research Centre, Institute for Prospective Technological Studies (JRC IPTS), the Directorate General for Communications Networks, Content and Technology (DG CNECT), and the Directorate General for Health and Food Safety (DG SANCO) (European Commission, 2011). The aim was to develop and implement a framework that can help estimating the health and economic outcomes of a large variety of social and technological innovations in the health and care sector targeting active and healthy ageing. These innovations are being developed and implemented by a total of 517 commitments (groups of stakeholders participating in the EIP on AHA) across all EU-countries (and beyond), which are organised in six thematic Action Groups (Table 1 and Figure 1) (Abadie, 2014a). The monitoring framework developed comprises a web- based tool which rests on a Markov process and aims at estimating the impact of the EIP on AHA activities on health and on the sustainability of health and social care systems (Boehler, 2015a). More precisely, the MAFEIP-tool allows estimating the change in quality adjusted life expectancy related to the activities carried out in the EIP on AHA and the estimated impact of a social or technological innovation on health and social care expenditure in a particular context (Boehler, 2015a). The tool builds up from a variety of surrogate

MATERIALS AND METHODS endpoints commonly used across the diverse set of EIP on AHA commitments in order to estimate health and economic outcomes in terms of incremental changes in Quality adjusted life years (QALYs) as well as health and social care utilisation (Boehler, 2015b). A highly adaptable Markov model with three mutually exclusive health states ('baseline health', 'deteriorated health' and 'death') provides the basis for the tool which draws from an extensive database of epidemiological, economic and effectiveness data; and also allows further customisation through remote data entry enabling more accurate and context specific estimation of intervention impact. Both probabilistic sensitivity analysis and deterministic scenario analysis allow assessing the impact of parameter uncertainty on intervention outcomes. A set of case studies, ranging from the pre-market assessment of early healthcare technologies to the retrospective analysis of established care pathways, will be carried out before public rollout, which is envisaged end 2015. Monitoring the activities carried out within the EIP on AHA requires an approach that is both flexible and consistent in the way health and economic impact is estimated across interventions and commitments. The added value for users of the MAFEIP-tool is its ability to provide an early assessment of the likelihood that interventions in their current design will achieve the anticipated impact, and also to identify what drives interventions' effectiveness or efficiency to guide further design, development or evaluation.

3.2.3.4.6 Materials and Methods used for the consolidation of the descriptive component of the Framework: . Open ended questionnaires were delivered to healthcare stakeholders, to discuss the results of the user needs elicitation activities. . Iterative validation of Multidisciplinary Requirement, a method described in section 3.2.3.3, was used to discuss the results of the requirement elicitation activities; . Documents were sent to experts on HTA and Health Economy to discuss on how the impact indicators and the scaling-up guidance, have been included and represented in the framework. . The entire framework was presented as an academic presentation, given to experts and non-experts in healthcare innovation, who were attending (as faculty members and as students, respectively), the 2nd IEEE EMBS Summer School on Emerging Technologies and Applications in Telemedicine25. After the presentation, a focus group was held, to discuss on the main impressions, which the presentation of the framework, had generated to the audience.

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3.2.4 Phase 3: creation of the procedure to evaluate multidisciplinary teams innovating in healthcare.

This section describe the materials and methods used to create a new instrument, suitable to evaluate the innovation team in the creation of solutions for CD management.

Latest advances in this aspect are provided by the research team field and from translational health. In addition, techniques from health technology assessment disciplines (learnt during the IFMBE summer school on HTA) have been used. These techniques allows to perform synthetic and yet accurate judgements on the different elements that concur in the evaluation of a healthcare innovation.

3.2.4.1 Multidisciplinary Translational Team (MTT) methods from Translational Health research. The growth in science and engineering teams has dramatically accelerated since 1975, and research collaborations that include multiple institutions are now the fastest growing authorship structure (Jones, Wuchy, & Uzzi, 2008). This transition has been accelerated by the recognition that specialized scientific fields must develop collaborations to enhance creativity and accelerate discovery to address major societal health problems (Disis & Slattery, 2010). “Research products developed by scientific teams indicate more frequent citations and greater impact than that from siloed investigators” (Wuchty, Jones, & Uzzi, 2007).

The Clinical and Translational Sciences Award (CTSA) is a “National Institutes of Health (NIH) Roadmap initiative, intended to stimulate the production and effectiveness of translational research” (Zerhouni, 2006).

Translational research attempts “to identify potential treatments from therapeutics or interventions derived from basic laboratory research, examine findings when applied to routine clinical practices, and convert treatments into standards of practice or public health policy (Sung et al., 2003; Westfall, Mold, & Fagan, 2007)” (Zerhouni, 2006).

A major strategy is to promote team-based multidisciplinary research.

Recently, an implementation model for multidisciplinary translational teams (MTTs) has been proposed (Calhoun et al., 2013):

“The MTT is a hybrid structure that involves academic goals for knowledge generation and training with product-driven goals to develop devices or interventions for clinical application.

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MTTs are composed of a strategic core of multidisciplinary investigators dynamically engaged in training, capacity development, and product generation” (Calhoun et al., 2013).

The interdependence and heterogeneous membership promotes innovation and effectiveness (Van der Vegt&Janssen, 2003).

As noted by Hall et al. (2008) and by Calhoun et al. (2013), translational teams evolve in terms of team processes as they mature, and make adaptive changes in relation to differing stages of the translational continuum (i.e., from discovery to treatment), thus making them complex.

Because translational research utilizes team science processes and structures (Börner et al., 2010), identification of appropriate evaluation models, methods, and techniques is much needed (Hall et al., 2008; Masse et al., 2008).

Recent work illustrates a range of methods to evaluate team science, including survey methods (Masse et al., 2008), social network analysis (Aboelela, Merrill, Carley, & Larson, 2007), action research (Stokols, 2006), interviews and focus groups (Stokols et al., 2003), and improvement-oriented approaches using multiple methods (Gray, 2008).

Börner et al. (2010) and others (Klein, 2006; Stokols et al., 2003; Trochim, Marcus, Masse, Moser, & Weld, 2008) have suggested that a mixed-method approach is necessary to capture and assess the complexity of team science. Mixed-methods research produces more evidence than either qualitative or quantitative approaches could by themselves, and the ‘‘combination of strengths of one approach make up for the weaknesses of the other approach’’ (Creswell & Clark, 2011, p. 2).

To address the complexities involved in assessment and evaluation of an MTT, the MTT draw on concepts and techniques from outcome-based evaluation, process evaluation, and developmental evaluation (Wooten et al., 2013):

. Outcome-based evaluation is a systematic determination if a program has achieved its goals (Hoggarth & Comfort, 2010). Relevant assessment methods useful for quantifying MTT outcomes could include artefact/unobtrusive measures assessment, an assessment focused on the products of the MTT, or bibliographic assessment, a tool that would suggest the impact of the MTT in the larger scientific context. . Process evaluation is an iterative process that focuses on revealing program effectiveness (Saunders, Evans, & Joshi, 2005). Relevant assessment methods include direct observation, structured interviews, surveys, and social network analysis on program processes and program implementation. This information stimulates discussion, inquiry, and insight into adopting programmatic change. . Developmental evaluation is a technique focused on continuous improvement supporting team adaptation under dynamic and evolving

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conditions in real time (Patton, 2010). In a manner distinct from process evaluation, this type of evaluation allows for direct, user-based feedback and focuses the participants to implement innovative change with the team.

In order to assess MTTs, an expert panel is needed (Coryn, Hattie, Scriven, & Hartman, 2007; Lawrenz, Thao, & Johnson, 2012). The involvement of experts help to reduce assessment data and to balance the objective data with contextual specificity and interdisciplinary focus (Huutoniemi, 2010; Klein, 2006). The expert panel suggested includes

. the Principal Investigator, . the Director and Assistant Director of Research Coordination, . a consulting team coach, . a consulting evaluator,

representing a range of disciplines (medicine, clinical research, psychiatry, psychology, and management).

Each expert panel member is asked to independently review logic models, measurement plans, and all assessment data to determine, by rating a given team’s performance as 0 (not present), 1 (low), 2 (medium), or 3 (high).”

3.2.4.2 Health Technology Assessment Core Model® Handbook. The HTA core model handbook (Lampe, 2008) is a guide for people who conduct assessments and need to produce HTA information. It is based on an HT Core Model (Lampe, 2009) that divides information into assessment elements (aspects to consider when deciding whether or not to adopt a technology) and core elements (to be shared in the international context).

The European network for HTA, EUnetHTA, “established to create an effective and sustainable network for HTA across Europe […..] to help developing reliable, timely, transparent and transferable information to contribute to HTAs in European countries” provides, in their webpage, a guidance on the HTA core model® Handbook.

Each element describes one or more aspects of the technology that is likely to be useful when considering whether or not to use the technology.

These pieces of information are referred to as assessment elements. The elements that are most likely useful to share in the international context are defined as core elements. Each assessment element contains a generic, i.e. a non-technology-specific question referred to as an issue. The issues define in a generic manner the aspects of technology that one should consider.

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3.2.5 Phase 4. Materials used to validate the Framework.

In this section, the materials and methods selected to validate the framework, are presented.

3.2.5.1 Why a case study? Case study research is the best method to use when the objective of the research is to understand a complex issue.

Researchers have used this method for different disciplines, with a big prevalence of social sciences, to examine real-life situations and provide insights towards application of ideas and extension of methods.

Yin defines the case study research method as “an empirical inquiry that investigates a contemporary phenomenon within its real-life context; when the boundaries between phenomenon and context are not clearly evident; and in which multiple sources of evidence are used” (Yin, 1984; Yin, 2010).

Critics are not scarce to this methods: there is the risk that not solid grounds for reliability or generality of results can be generated or that the exposure to study biases findings, while others suggest this method is useful only as an exploratory tool. Important case study researchers have written about this method and suggest techniques for organizing and conducting research successfully.

Six steps are usually suggested when conducting a case study:”

1. Determine and define the research questions: case study research generally answers one or more questions which begin with "how" or "why." 2. Select the cases and determine data gathering and analysis techniques: during the design phase of case study research, the researcher determines what approaches to use in selecting single or multiple real-life cases to examine in depth and which instruments and data gathering approaches to use. Selecting multiple or single cases is a key element, but a case study can include more than one unit of embedded analysis. This type of case study involves two levels of analysis and increases the complexity and amount of data to be gathered and analysed. 3. Prepare to collect the data: case study research generates a large amount of data from multiple sources, therefore, systematic organization of the data is important to prevent the researcher from becoming overwhelmed by the amount of data and to prevent the researcher from losing sight of the original research purpose and questions. Good investigators review documents looking for facts, but also read between the lines and pursue collaborative evidence elsewhere when that seems appropriate. Investigators need to be flexible in real-life situations and not feel threatened by unexpected change, missed appointments, or lack of office

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space. Investigators need to understand the purpose of the study and grasp the issues and must be open to contrary findings. 4. Collect data in the field: the researcher must collect and store multiple sources of evidence comprehensively and systematically, in formats that can be referenced and sorted so that converging lines of inquiry and patterns can be uncovered. 5. Evaluate and analyse the data: the researcher examines raw data using many interpretations in order to find linkages between the research object and the outcomes with reference to the original research questions. Throughout the evaluation and analysis process, the researcher remains open to new opportunities and insights. The case study method, with its use of multiple data collection methods and analysis techniques, provides researchers with opportunities to triangulate data in order to strengthen the research findings and conclusions. 6. Prepare the report: exemplary case studies report the data in a way that transforms a complex issue into one that can be understood, allowing the reader to question and examine the study and reach an understanding independent of the researcher. The goal of the written report is to portray a complex problem in a way that conveys a vicarious experience to the reader.”

3.2.5.2 Design of the Case Study: participant observation. “Participant observation is the process enabling researchers to learn about the activities of the people under study in the natural setting through observing and participating in those activities. It provides the context for development of sampling guidelines and interview guides” (De Walt & De Walt, 2002).

Schensul et al. define participant observation as "the process of learning through exposure to or involvement in the day-to-day or routine activities of participants in the researcher setting" (Schensul et al., 1999).

Bernard defines participant observation as “the process of establishing rapport within a community and learning to act in such a way as to blend into the community so that its members will act naturally, then removing oneself from the setting or community to immerse oneself in the data to understand what is going on and be able to write about it” (Bernard, 1994).

More elements than just observation are present, according to Bernard, when the observant is also a participant; observation, natural conversations, and interviews of various sorts, checklists, questionnaires, and unobtrusive methods.

“Participant observation is characterized by such actions as having an open, non-judgmental attitude, being interested in learning more about others, being aware of the propensity for feeling culture shock and for making mistakes, the majority of which can be overcome, being a careful observer and a good listener,

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MATERIALS AND METHODS and being open to the unexpected in what is learned” (DeWALT & DeWALT, 1998).

DeWALT and DeWALT (2002) believe that "the goal for design of research using participant observation as a method is to develop a holistic understanding of the phenomena under study that is as objective and accurate as possible given the limitations of the method”.

Validity is stronger with the use of additional strategies used with observation, such as interviewing, document analysis, or surveys, questionnaires, or other more quantitative methods.

Participant observation can be used to help answer descriptive research questions, to build theory, or to generate or test hypotheses (DeWALT & DeWALT, 2002).

DeMUNCK and SOBO (1998) provide several advantages of using participant observation over other methods of data collection:

. it affords access to the "backstage culture"; . it allows for richly detailed description, which they interpret to mean that one's goal of describing "behaviours, intentions, situations, and events as understood by one's informants" is highlighted; . it provides opportunities for viewing or participating in unscheduled events. . it improves the quality of data collection and interpretation; . it facilitates the development of new research questions or hypotheses.

DeMUNCK and SOBO also share several disadvantages:

. the researcher may not be interested in what happens out of the public eye and that one must rely on the use of key informants. . The MEAD-FREEMAN controversy illustrates how different researchers gain different understanding of what they observe, based on the key informant(s) used in the study. . Problems related to representation of events and the subsequent interpretations may occur when researchers select key informants who are similar to them or when the informants are community leaders or marginal participants (DeMUNCK & SOBO, 1998).

To alleviate this potential bias problem, Bernard suggests pretesting informants or selecting participants who are culturally competent in the topic being studied (Bernard, 1994).

The degree to which the researcher involves himself/herself in participation in the culture under study makes a difference in the quality and amount of data he/she will be able to collect. GOLD (1958) has provided a description of observer stances that extend Buford JUNKER's explanation of theoretical stances for researchers conducting field observations:

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1. “At one extreme is the complete participant, who is a member of the group being studied and who conceals his/her researcher role from the group to avoid disrupting normal activity. The disadvantages of this stance are that the researcher may lack objectivity, the group members may feel distrustful of the researcher when the research role is revealed, and the ethics of the situation are questionable, since the group members are being deceived. 2. In the participant as observer stance, the researcher is a member of the group being studied, and the group is aware of the research activity. In this stance, the researcher is a participant in the group who is observing others and who is interested more in observing than in participating, as his/her participation is a given, since he/she is a member of the group. This role also has disadvantages, in that there is a trade-off between the depth of the data revealed to the researcher and the level of confidentiality provided to the group for the information they provide. 3. The observer as participant stance enables the researcher to participate in the group activities as desired, yet the main role of the researcher in this stance is to collect data, and the group being studied is aware of the researcher's observation activities. In this stance, the researcher is an observer who is not a member of the group and who is interested in participating as a means for conducting better observation and, hence, generating more complete understanding of the group's activities. 4. The opposite extreme stance from the complete participant is the complete observer, in which the researcher is completely hidden from view while observing or when the researcher is in plain sight in a public setting, yet the public being studied is unaware of being observed. In either case, the observation in this stance is unobtrusive and unknown to participants”

3.2.5.3 Description of the Case Study. The case study is related to the R&D&I activities that the LifeStech research group, of the Universidad Politécnica de Madrid has carried out to improve the management of diabetes since January 2008 till the present date,

These activities started when the METABO research project was funded by the European Commission (European Commission, 2008). In this project, a community of stakeholders active in the healthcare sector of different countries of the European Union worked together for almost 5 years to define, implement, deploy and evaluate a new paradigm in the management of Diabetes Mellitus Type 1 and Type 2, in the area of Personalized Health Systems.

The LifeStech group was represented in the METABO project by the author of this research work, who acted as technical manager of the project. After the end of the project (September 2012), the R&D&I activities undertaken in the LifeStech group, in relation to the case study, have continued and are ongoing till the present days. The case study represents a suitable scenario to test the framework, because:

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. It is about improving the management of diabetes, an important case of chronic disease, given its prevalence, and given the positive effects that the application of the CCM has demonstrated, as mentioned in chapter 1, . It is based on activities that contain different aspects of the innovation process: applied research, deployment and piloting, as well as organizational, marketing and business-oriented elements. . It has a retrospective component: this way it is possible to show how the framework works in evaluating past interventions. . It has a prospective component: this way it is possible to show how the framework influence future directions. . It is complete, as it contains all the 3 development cycles of innovation. . It is wide in terms of number of participants, multidisciplinarity and variety of European regions that constitute the project consortium.

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4. RESULTS

”Happiness is when what you think, what you say, and what you do are in harmony.”

(Mahatma Gandhi).

Chapter 4 presents the results of the research work. As for the phases described in the previous chapters, results are mapped to the hypothesis and objectives. The delivery of the results is developmental: each result is generated from the results of the previous Phase. The final result consisted in the validation of project results through the execution of a case study, presented and discussed at the end of the chapter.

RESULTS

Introduction

As described in the methodological section and summarized here, each result derives from the activities carried out to achieve each objective and verify the corresponding hypothesis. The achievement of the results has been obtained through a developmental approach, that is, each result is generated from the result of the previous phase, while the first result starts from the JBI model of evidence-based healthcare.

. Result 1, a Knowledge Translation Process to put Evidence-based Chronic Care into action through innovation = JBI model of evidence-based healthcare + 4 Innovation Blocks where each Innovation Block is a set of rules that defines:

1. The elements of an evidence-based model of chronic care open to innovation; 2. A Clinical/eHealth Domain Translation + 3. A requirement elicitation phase to accelerate Knowledge Transfer 4. A definition of Key Performance Indicators to evaluate the impact.

. Result 2, the descriptive component of the framework = Result 1+”The best available evidence” for each domain of the Innovation Blocks. . Result 3, the procedural component of the framework = R2 + Mixed-method to evaluate Multidisciplinary Translational Team +HTACoreGuide® . Result 4, the Reference Framework =R3+ Case Study

Taken together the results allows to achieve the main result of this research work:

R=R1+R2+R3+R4 = a bridge between innovation and healthcare.

The next sections of this chapter present the four results.

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Result 1: a Knowledge Translation Process to put Evidence-based Chronic Care into action through innovation.

The 4 elements of the JBI model of evidence-based healthcare have been expanded in order to add an innovative dimension, based on the conclusions of chapter 1, summarized in Table 1.

Below, the definition of each component of the JBI model is given in Italic, while the definitions of the four innovative blocks are given as highlighted text.

. Healthcare evidence generation. Evidence may derive from different experiences, however, the results of well-designed research studies grounded in any methodological position are seen to be more credible as evidence than anecdotes or personal opinion. When no research evidence of this level exists, other evidence may represent the “best available evidence” for a specific question.

 The best available evidence about models of chronic care needs to be identified, in terms of efficiency, cost-effectiveness and health outcomes, to be shared with active modern citizens  The model has to include a description of a cultural narrative and interventions that specify how and by who the evidence should be put in place.  The model should enable the context to innovation, allowing continuous bottom-up integration of results from early research.

. Evidence synthesis. Evidence synthesis is the evaluation or analysis of research evidence and opinion on a specific topic to aid in decision making in healthcare. The increasing, ongoing interest and theoretical work on methods of synthesizing evidence from diverse sources are depicted as an element of evidence synthesis.

 The model and its components, needs to be divided in atomic elements of the eHealth domain.  The atomic elements are user expressions that describe a requirement to be satisfied.  The synthesis must identify also the actors involved in the realization of the requirements.

. Evidence/knowledge transfer; This component of the model relates to the act of transferring evidence (knowledge) to individual health professionals, health facilities, and health systems, by identifying methods to package and transfer information that is understood and used in decision making.

 User expressions are now translated into structured and specified requirements or specifications.

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 The translation of the “Narrative user expressions” is a specification of Goals and Outcomes.  The translation of “narrative user expression” is a set of categorized Specifications that are transferred to different group of stakeholders, for each category.

. Evidence utilization. This component of the model relates to the implementation of evidence into practice, as is evidenced by practice and/or system change. It identifies three elements: evaluating the impact of the utilization of evidence on the health system, the process of care and health outcomes; practice change; embedding evidence through system/organizational change.

 Each specification is processed to derive quantified, measureable and tangible Key Performance Indicators (KPIs) to assess the design, the implementation and the evaluation of innovative interventions for chronic care:

o User Needs KPIs, to assess the Goal and Outcomes o KPIs to verify that the specifications have been correctly implemented. o KPIs to demonstrate efficacy, cost-effectiveness, sustainability and transferability of an innovation.

The following KPT has been defined, divided in 4 Innovation Blocks, mapped with the 4 elements of the JBI model but enriched with the above innovation rules.

Figure 35 – KTP to transform a model of care into a framework to assist multidisciplinary research teams in design, implementation and evaluation innovative solutions.

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Result 2: towards the descriptive component of the framework

Once the KTP was defined, the best available materials for each innovation block were used, in order to transform a model of chronic care into a structured description of Goals, Needs, Requirements and KPIs.

This resulted in a structured description of the characteristics of the design, implementation and evaluation phases that an innovation for chronic care should possess.

The selection of has been justified in sections 1.2 and 3.2, and summarized here:

. Innovative Block 1: the best available evidence for chronic care is the Chronic Care Model. It has demonstrated evidence throughout all its components and in different countries. Complete evidence of the CCM has not been demonstrated, however it is also used by policy makers and decision makers to create a cultural narrative, stimulate system thinking and bottom-up integration of innovative and cost-effective research results. Given the European context in which this research work is taking place, the ARCHO instrument, adapted from the work of the RAND institute, has been selected as an instrument that structure the CCM in a set of interventions. The ARCHO instrument has been adapted to a European context and has been thoroughly validated, that is why was used as the best available evidence. . Innovative Block 2: concept maps and the taxonomy of problem ontology domain have been selected. These methods have been extensively used in representing knowledge of a variety of domains, including ICT and innovation-oriented domains (i.e. eHealth). . Innovative Block 3: the CeHRes Roadmap, built on top of existing evidence based frameworks for eHealth interventions. The roadmap provides guidance on how to structure the definition of innovative solution in different phases, it is holistic, business oriented and equipped with persuasive techniques. For this reason, it has been selected as best available evidence to use eHealth as a catalyst for innovation. . Innovative Block 4: the best available evidence indicators to assess innovations have been selected. By definition, an innovation involves elements that are developed at “early-stages” (i.e. early design, early implementation and early delivery of ideas, mock-ups, prototypes or pre- industrial products). For this reason, the instruments that provides indication on early Health Technology Assessment have been selected. Building on top of the indicators suggested by the CeHRes roadmap, which inform on the uptake, healthcare delivery, health and wellbeing impact, these indicators have been enriched with those ones provided by the MAFEIP project and the Scaling-up Strategy of Innovations on AHA have been considered as the best available evidence.

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Figure 36 - KTP+Innovation Block+"Best Available Materials and Methods"

In Figure 37, the steps executed to transform the Chronic Care Model in the Multidisciplinary Framework are represented.

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Figure 37 - Building the Framework: flow diagram showing the translation process and, for each block, the methods and the outputs generated .

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For each block, the methods described in chapter 3 have been used. The input is the Chronic Care Model, the output is the descriptive component of the framework, organized in 3 cycles of the innovation development (design, implementation and evaluation). Next sections detail the intermediate transformational steps that were executed, in order to transform the input in the desired output.

4.3.1 Block 1. The CCM processed through the ARCHO Instrument

The Chronic Care Model is composed of 6 dimensions, 2 outcomes and one goal. The ARCHO instrument further decomposes the 6 dimensions into 27 components and 80 interventions, turning it into a systemic instrument for “supporting organizations pursuing integrated management of chronic diseases, encompassing public health, prevention, health care and coordination with social care”.

4.3.2 Block 2. CCM components transformed in CMaps and User Expressions

The CCM-ARCHO is described through 27 concept maps, through which it is possible to finally decompose the CCM into a set of 82 (2 outcomes + 80 components from the 27 interventions) atomic user expressions and extract requirements for each one of them.

Two examples, leadership commitment and strategic framework, which represent the first two component of the 1st Dimension of the CCM, ORGANISATION OF THE HEALTH SYSTEM are provided respectively in Figure 38 and Figure 39, while the full list of concept maps has been included in Annex 2.

Each user expression is then categorized (see Figure 40) as an action (red colour), a concept (blue colour), or a predicate (green colour), using the taxonomy of the problem domain description described in Table 8. The definitions of the taxonomy were used also to identify actors.

The output of this block consists of 1 problem domain, 3 groups of actors, and the 6 dimensions of the CCM, organized in 7 actions, 47 concepts and 26 predicates.

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Figure 38 – Example of Concept Map describing the first component (leadership commitment) of the first dimension (ORGANISATION OF THE HEALTH SYSTEM) of the Chronic Care Model. It is characterized by 4 actions (or behaviours) and 1 definition (leaders).

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Figure 39 – Example of Concept Map describing the second component (Strategic framework) of the first dimension (ORGANISATION OF THE HEALTH SYSTEM) of the Chronic Care Model. It is characterized by 1 action, 1 concept (or condition, accompanied with a descriptive example) and 1 predicate.

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Figure 40 – the Strategic Framework component categorized in actions (red), concepts (blue) and predicates (green).

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4.3.3 Block 3. Restructuring Knowledge

The outputs of Block 2 have been processed through the CeHReS roadmap in the following way:

. The 2 outcomes of the CCM (patient activation + proactive and prepared care team), whose achievement will bring to reach the main goal (also referred as healthcare problem to solve) to achieve (productive interactions), was processed through the CeHRes Contextual Inquiry part A (Problem Setup). In particular, the Analytic Hierarchy Process was used, to decompose the two core elements in two hierarchies of factors. These hierarchies have been iteratively defined, with the support of 6 healthcare professional experts from the EIPonAHA. Then, 3 groups of experts (n=5, 6 and 7) from the EIPonAHA ranked the hierarchies for three target groups, healthy citizens, chronic patients and patients with dependency. The result is a quantitative and qualitative assessment of the needs to be considered in the design of innovative solutions for chronic care, with specific priorities for each one of the 3 target groups. . Then, the CeHRes Contextual Inquiry part B (“Stakeholder Analysis”) is used, to identify and describe the main stakeholders. Definition of stakeholders were taken from those provided by the ARCHO instrument. . As regards Actions, Concepts and Predicates, they were processed through the CeHRes Value Specification and Design phases. According to the CeHRes taxonomy, Actions are now referred as Behaviour Specifications (an action which a stakeholder has to take); Concepts are now renamed as Value Specifications (an improvement stakeholders want to realize in healthcare); Predicates were considered as System Specifications (a structured collection of information that embodies the requirements of a system), and were processed through the multidisciplinary requirement development approach, described in section 3.2. . Finally, the CeHReS Operationalization and the Summative Evaluation phases were used to identify Key Performance Indicators (KPIs) of the clinical impact and uptake of a given intervention, and enriched with the instruments and guidance provided by the EIPonAHA Monitoring Framework (the MAFEIP tool) and EIPonAHA Reference Site working groups (the Scaling-up Strategy), adding KPIs on cost-effectiveness, maturity, and transferability potential of a given intervention.

The outputs of this block are;

. 2 hierarchies of needs and a stakeholders analysis . A translation table specifying 80 multidisciplinary requirements. . A set of KPIs, to assess cost-effectiveness, viability, impact and uptake of the innovative solution.

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4.3.4 Block 4. Assessment

This block delivers as output a set of instruments that are able to represent, in a synthetic, structured and measurable fashion, a description of goals, needs and specified requirements of the Chronic Care Model. This description is organized in three Development Cycles:

1. Design cycle. The 2 hierarchies of healthcare improvements, agreed and ranked by the experts, can be used as a qualitative and quantified instrument to quantify how the design of the solution covers the expected needs. 2. Implementation cycle. The translation table specifies how to process each one of the 80 components. Each group of requirement can be used to communicate with a specific group of people (e.g. technologists understand requirements, marketing departments use attributes, and policy makers prefer values):

. In the case of Behaviours Specifications, the Fogg Behavioural Model (FBM) has been used to determine the elements needed to support such behaviour, as well as the elements to verify if they have been adopted. . In the case of Values Specifications, interviews (used to uncover stakeholders’ opinions, motivations and wishes regarding the specification), focus groups (to establish the context, roles and primary tasks that are or could be supported by the VS, and what business model should support this) and observations (useful for understanding social, physical and spatial surroundings of stakeholders) are used to verify if the value has been realized. . In the case of System Specifications, functional and usability tests are suggested.

3. Evaluation cycle. This section describe how to evaluate an intervention. KPIs have been defined in the following way:

. The Operationalization, Monitoring and Dissemination steps, defined in the Scaling-up strategy on Active and Healthy Ageing have been used to define the steps to execute when performing an assessment on how the innovation is being deployed. Within these steps: . The CeHRes Summative Evaluation checklist, which provides a list of indicators to be used for impact and uptake assessment, has been included. . The MAFEIP tool, used to perform a cost-effectiveness analysis of the intervention, has been included.

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Result 2: the Descriptive Component of the Framework

In this section, the descriptive component of the framework is presented.

The outputs of the KTP have been organized in the 3 cycles of innovation. At the beginning of each sections, the procedures of the CeHRes Roadmap are presented in boxes.

4.4.1 Design Cycle

From the CeHRes Roadmap, Context Inquiry Phase, Part A: Identify the Problem. What is the Healthcare Problem? . Tasks performed by the multidisciplinary team:  Discuss the problem from different stakeholders’ point of views.  Categorize the problem according into core healthcare problems.  Prioritize the problem/need that has to be solved.  Deciding Upon the overall goal(s)

The Healthcare problem is:

Improving Chronic Management through the Implementation of the CCM, with the objective of establishing productive interactions between an activated patient and a proactive and prepared care team.

The healthcare problem was discussed with experts from the EIP on AHA. They were 5 senior clinicians working in a variety of clinical specializations and departments of European healthcare institutions: two nurses specialized in patient activation in the Basque Country region, Spain, one medical doctor specialized in medical and health professional education from the Murcia region, Spain, one nurse specialized in gerontology and one medical doctor and head of department in gerontology from the Cork County, Ireland. After a first round of iteration, a draft representation of the hierarchies have been drawn. Then, after two rounds of iterations, the final hierarchies have been defined, they are presented in Figure 41 and Figure 42.

In the case of PATIENT ACTIVATION, 12 needs, organized into 4 meaningful categories (BELIEF, BEING CONFIDEND AND INFORMED, BEING PROACTIVE, MAINTANING LIFESTYLE CHANGES) have been identified. It was also decided to further develop the definition of 6 of 12 needs, into subcategories, because these concepts needed a more precise specification, in order to avoid lack of clarity.

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Figure 41 - Hierarchic Categorization of the PATIENT ACTIVATION "HC Problem".

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In the case of the PROACTIVE AND PREPARED team hierarchy, after a first iteration, it was decided to have a hierarchy organized in 2 levels instead of 3, meaning that the concept of PATIENT ACTIVATION is more structured than this one. The hierarchy is composed of 13 needs organized in 4 categories (DATA REVIEW, INTERVENTION, SOLVING PROBLEMS FOR IMPROVING SELFMANAGEMENT, and FOLLOW-UP).

Figure 42 - - Hierarchic Categorization of the PROACTIVE AND PREPARED CARE TEAM “HC Problem”.

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Then, the hierarchies have been mapped with technologies by a group of 3 system designers (one system analyst, one human computer interaction expert, one system developer, the entire process has been described in (Fico, 2014)). The technology mapping for the concept of PATIENT ACTIVATION is presented in Figure 43, while the one for the PROACTIVE AND PREPARED team is presented in Figure 44.

Figure 43 - Technology mapping for PATIENT ACTIVATION.

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Figure 44 - Technology mapping for a PROACTIVE AND PREPARED CARE TEAM.

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In parallel, each need and factor of the two hierarchies has been ranked by 3 groups of experts (n=5+6+7) in 3 Areas: 1) citizens, 2) chronic patients and 3) patients with dependency. The results obtained in the case of chronic patients are presented herein. The tables below shows the results of this ranking (given as percentage over a total of 100%), the discussion focused on the first and second levels of the hierarchy, for the sake of easing the discussion process with the experts.

Table 10 – Needs for PATIENT ACTIVATION ranked in the case of Chronic Patients.

Level 1 HAVING AN ACTIVATED BELIEFS Being CONFIDENT BEING PROACTIVE MANTAINING +65 PATIENT AND INFORMED lifestyle changes Group result 9% 41% 24% 26% Level 2 BELIEFS be RESPONSIBLE for HC professionals not main ACTIVE ROLE determines managing health actors wellness Group result 39% 12% 48%

Being CONFIDENT AND CARE PLAN SELF MANAGEMENT HEALTH CONDITION INFORMED Group result 41% 32% 27%

BEING PROACTIVE DECISIONS LIFESTYLE Management SELF-CARE Group result 34% 38% 27%

MANTAINING lifestyle during times of STRESS AGAINST things one wants ON daily basis changes to do Group result 30% 32% 38%

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Table 11 - Needs for PROACTIVE AND PREPARED CARE TEAM ranked in the case of Chronic Patients

Level 1

A PROACTIVE AND REVIEW DATA WHEN APPLY CLINICAL- WORK ON PROVIDING PREPARED CARE TEAM MANAGING BEHAVIOURAL IMPROVING SELF- CONTINUOUS CONDITION INTERVEN MANAGEMENT FOLLOW-UP

Group result 18% 32% 28% 23%

Level 2 REVIEW DATA WHEN MANAGING The ORGANIZATION The TEAMWORK The DATA ASSESSMENT The PATIENT CONDITION EMPOWERMENT Group result 17% 25% 23% 34%

APPLY CLINICAL-BEHAVIOURAL Making use of CLINICAL GUIDELINES Involving the PATIENT Working as a TEAM INTERVEN Group result 20% 45% 35%

WORK ON IMPROVING SELF- GOAL SETTING THERAPEUTIC ALLIANCE COACHING MANAGEMENT Group result 19% 40% 41%

PROVIDING CONTINUOUS FOLLOW-UP through REMOTE MONITORING COMMUNITY RESOURCES&INITIATIVES SCHEDULING Group result 38% 39% 23%

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The results have been analysed and discussed with the domain experts, by providing them a questionnaire (included as ANNEX 4) with open-ended questions related on the results:

. ACTIVATION:

 All in all, they agree with the results, even though too low importance seems to be given around the Belief concept, while the others seem to be balanced. However, the role that the patient has in the management of disease seems to be secondary to the information concept.  The tree can be used by healthcare professionals when making first interviews with patients and defining a care plan because and serving as an outline and as an indicator. By analysing each one of these concepts a valuable and global vision of the patient status would be reached and thus providing an important aid when agreeing care plan among patients and care providers.  This tool can benefit patient-provider interaction and optimize time of visits (as it acts as a script of points that have to be touched and not to forget).

. PROACTIVE and PREPARED CARE TEAM:

 the ranking were agreed by the experts. Involving the patient, therapeutic alliance and coaching seem to be the most important one. For this reason, it is important to improve this aspects in healthcare systems, for instance by providing health coach training and tools that really help working in teams with their patients.  The tree could be used by healthcare managers to work with their teams  The tree could be used as a mean to make the needed changes and put in actions the concepts above identified.

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From the CeHReS Contextual Inquiry-B: Stakeholder Analysis Who has a stake in addressing the problem? . Tasks  Invite the Stakeholders of the problem  Discuss who stakeholders are  Specify Roles and Task of Stakeholders

The Stakeholders identified are:

. Leaders (Managers, Clinical, etc.) . Health and Social Care Professionals, members of a HC team. . Informal Care Givers, Patient Groups (forum, social, etc.) and Patients.

The following definitions and concepts have been taken from the ARCHO instrument and are describing stakeholders in terms of roles, tasks and functions.

. Leaders: a “leader” is defined as any member of staff with a management role in healthcare organisations and those responsible for teams of staff, depending on the setting in question: regional health service, geographical healthcare area (e.g., district or region), hospital or health centre. The following elements are defined and related to leaders:

 Leadership: A process related to clinical activity in which some health professionals act as leaders with the aim of improving clinical practice and service provision. This is based on the development of competencies to drive strategies, inspire a vision and shared values in professional practice, foster teambuilding, create an organisational culture of innovation and excellence, and develop and prepare professionals for achieving effective management of health problems and excellent care for patients and families.  Population-based approach is understood as one which takes the entire population of a certain geographical area into consideration in the design of policies, strategies, and action plans for chronic care. Accordingly, it includes not just patients receiving care but also the healthy population in relation to health promotion activities, in general, and individuals who do not use health services but who could potentially benefit from them.  Population stratification systems: it refers to the classification of the population into groups that require different interventions or programmes depending on their health status, risk, complexity or needs. To date, the stratification models most widely used classify the population according to their risk of emergency hospitalisation and/or use of other services which imply increased costs in the future. This intervention is addressed from a planning perspective and is complemented by intervention

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 Information for management and clinical practice. It concerns the individual classification of each patient recorded in their medical record.

. Health and Social Care Professionals, members of a HC team.

 The healthcare contact person is the professional a given patient identifies as his/her reference in the event of any incidents or questions. The patient knows the name of this professional. It might be their primary care doctor or nurse, a person responsible for patient services or their hospital specialist, depending on the setting.  Professional healthcare competencies required for the management of chronic patients: this refers to the recognition and development of new competencies among health professionals and the development of new profiles with a combination of competencies, to ensure that professionals are better prepared to provide quality care to their chronic patients. Examples of the corresponding new roles may be: health coaching, telephone counselling and the examples discussed in 3.2.2, 3.2.3 and 3.2.4 (see Annex 1).  Professionals that are given the role of ensuring coordination and continuity of care, particularly in processes of transition between care settings and planning hospital discharge. These are professionals who participate actively in the planning process at the time of discharge of hospitalised or institutionalised patients, in order to ensure continuity in the care process, to maintain care at home or in other community settings, and to avoid readmission or institutionalisation. Examples would be liaison nurses and nurse case managers who fulfil this coordination function and ensure continuity of care.  Work is carried out in teams in hospitals and other settings. This refers to the rolling out of a team development strategy including the following key elements: identification of team members; definition of their roles and functions; definition of shared goals and corresponding targets, with systematic evaluation of targets reached; and specification of information and communication channels and how often they should be used so that effective cooperation among members is strengthened. The team may range from the basic care unit of the primary care physician and nurse to other larger multidisciplinary and/or inter-area care settings. They may be general or specialised in one or several conditions. 3.3.2 This refers to providing opportunities for professionals to come together and discuss issues of common interest, whether by organising structured activities (seminars, conferences, meetings, etc.) or providing more informal forums for interaction (social networks, knowledge management platforms, social activities, etc.).

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 The risk classification of patients in terms of their expected care requirements is included in their health record. This assessment includes the risk of admission, foreseeable complications during treatment, and limited social support, as well as other difficulties.

. Patients, informal caregivers and patient groups

 Remote interaction between patients and professionals. This includes telephone calls, as well as e-mail, traditional websites, and Web 2.0 technologies.  Group sessions are held. The objective is effective improvement in disease management to achieve improvements in health outcomes and a better quality of life. It is based on peer-led interactions, with exchange of knowledge, experience and know-how to produce a change in behaviour allowing effective management of the process.  Programmes of group activities fostering personal autonomy and patient health have been set up. Programmes such as group exercise classes, cooking lessons.  Patients are involved in defining problems, in the action plan for negotiating priorities and objectives, and in evaluating their own progress. Once a general assessment of a patient has been made, the professional sets a series of therapeutic objectives with an associated action plan that is a road map stating how the activities and measures required to manage the chronic process are to be carried out. This action plan is agreed with the patient taking into account his/her values and preferences.  Face-to-face interaction (clinical sessions, consultations between professionals, rotations, etc.) is used for the exchange of knowledge and expertise. This refers to the transfer of theoretical and empirical knowledge and experience between professionals to assist in the treatment of specific cases or to support training in specific areas. This transfer may occur between professionals with different levels of specialisation, different sectors/levels of care (such as primary care, hospitals, social services, public health) and different types of professionals (medical, nursing, pharmacy and others). It may take place in either one or both directions.

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4.4.2 Implementation Cycle

From the Value Specification and Design Phases of the CeHReS roadmap: . Research questions:  What improvements in the quality of care are desired by the stakeholders?  How can technology/innovation contribute to better quality of care?  In what manifestation can technology/innovation contribute?  Does the design of the eHealth technologies/innovations meet the stakeholder requirements? . Tasks performed by the project management team:  Identify key-stakeholders  Key-stakeholders rank the values  Stakeholders discuss in what modality they may contribute  Stakeholders discuss requirements  Test the design among experts (designers, technicians, researchers)  Test the design among the user target group

4.4.2.1 The CCM Translation Table of Specified Requirements A team of 4 biomedical engineers (the key stakeholders of this phase), experts in requirements elicitation and system analysis was involved in translating the CCM user expressions or quotes (output of block 3) into an ordered set of specified requirements. Requirement elicitation methods provide the tools to elicit the necessary input for each user expression. The translation process consisted in the process shown in Table 12 (taken from Van Velsen et al and readapted for this research work).

2 iterations took place with the stakeholders of this phase. One of them found it difficult to understand the concept of attribute. Another expert complained about the lack of a clear objective and reference motivation when performing this analysis. He also suggested the introduction of a new concept “mean”, to clearly elucidate how the value or attribute can be achieved and a more clear description of the verification method.

The result of this process was merged in a unique table for all the three types of specification. The translation tables for the 80 specifications of the Chronic Care Model are presented in the following section.

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Table 12 – Procedure adopted for the iterative Development of Multidisciplinary Specifications.

To aid the translation process, the analyst can complete a translation table. The translation table is filled with data from the Chronic Care Model. The following steps should be taken to ensure a reliable translation of data into requirements. 1. For each quote (i.e.: CCM intervention), the attribute or attributes are determined. An attribute should be formulated as a very short summary of the end user or stakeholder expression. 2. The analyst familiarizes him or herself with the elements of the Chronic Care Model. 3. Each element of the CCM is identified and listed in the “user expression” column. 4. For each quote, it is determined if it is a desired behaviour, a value or a system specification. 1. In the case of Behaviour Specification, the type of action, that is desired to be adopted, is specified. 2. In the case of Value Specifications, values and attributes are specified. Quotes are grouped on an attribute level. Quotes that can be transformed into the same attribute are merged in one row. For each value/attribute, the type of requirement is determined. 3. In the case of System Specification, the type of requirement is determined. 1. The analyst checks all quotes and the derivatives that flow from them, and determines whether they are correct and distinctive. If necessary, derivatives are adjusted. 2. An independent analyst checks the derivatives formulated. He or she notes disagreements or suggestions. Then, the initial and second analyst discuss these findings. 3. Derivatives are adjusted based on the discussion between the first and second analyst. 4. The first and second analyst determine the values together. Most often, there are only a few values that are linked to many attributes. Values should be formulated in a few words. 5. Once the translation table has been completed, the formative evaluations can be filled out. 6. Each derivative can be used to communicate with a specific group of people.

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4.4.2.1.1 Dimension 1: Organization of Health Care Table 13 - Translation Table for the CCM Dimension 1.

DIMENSION 1: Behaviour Value Specification: User Value Attribute(s) System Specification Type of Formative Evaluation Organization of Specification Expression action/attribu Health Care te/ requirement

1.1 Leadership BS 1.1.1: leaders Commitment developed an explicit vision of Chronic Care

BS 1.1.2: leaders have reallocated resources FBM: Green Dot+Path to drive transformation Action: Behaviours of the HC model with Leaders the aim of improving taking care for chronic decisions patients. BS 1.1.3: senior leaders promote clinical leadership among members of multidisciplinary teams. 1.2 Strategic VS 1.2.1: a strategic Strategic  Systematic Vision User Need: Verification of the Framework approach to CC is in place, Approach to Developed with Organization existence (document, based on a systematic vision CC in Place Stakeholders al interview, focus that was developed with the  Values, quality and group, observation collaboration of stakeholders responsible use of Review) bringing together values, resources quality and responsible use of resources. VS 1.2.2 Measurable Measurable Definition and User Need: Presence and objectives in the settings Objectives Dissemination in the Organization Knowledge of relevant to chronic care have relevant settings al Measurable been defined and Objectives disseminated. SS 1.2.3: a system for Organizationa Verification of the monitoring strategic l and existence (document, planning (process and Functional interview, focus outcomes) in chronic group, observation care is in place. Review) and Functional Test

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1.3 Population VS 1.3.1: the Care Model is Care Model Measure Progress by User Need: Measured Progress of Based Approach. geared to improving health geared to Indicators Organization the Care Model. and reducing inequalities and improve health al Verification of the its progress is measured by Care Model User Need: existence (document, indicators. geared to Organization interview, focus reduce al group, observation inequalities Review) SS 1.3.2: population Organizationa Verification of the stratification systems l and existence (document, providing useful Usability&UX interview, focus information for clinical group, observation and management Review) and Usability decisions have been & UX Tests devised and rolled out. 1.4 Information SS 1.4.1: the structure of Organizationa Verification of the system for the information system l and existence (document, evaluation, for evaluation, Usability&UX interview, focus improvement and improvement and group, observation innovation. innovation has been Review) and Usability defined and there is & UX Tests awareness of it. VS 1.4.2: measurements of Measurement Measurements “Taken User Need: Presence of quality, health outcomes and s of Quality, into consideration” Organization Measurements. efficiency are taken into Health (specify meaning) al Verification of the consideration in the care of Outcomes and existence (document, chronic conditions. Efficiency interview, focus group, observation Review). VS 1.4.3: methods for Collaborative Methods are in Use User Need: Nr. Of CL in Use collaborative learning, as well Learning Service as identification and Good Practice Nr. Of GP in Use dissemination of good practice are in use. BS 1.4.4: innovation Action: FBM: Green Dot+Path with the participation of Stakeholders Behaviours all stakeholders is work encouraged. Together

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1.5 Funding VS 1.5.1: a risk-adjusted per Funding Risk-Adjusted Per User Need: Nr. Of Incentives Scheme capita funding scheme has Scheme Capita Organization Rolled Out. been rolled out. al Verification of the existence (document, interview, focus group, observation Review) VS 1.5.2: incentives are in Improved Incentives for Shared User Need: Nr. Of Incentives In place for reaching shared Quality of targets Organization Place. Verification of targets in areas of chronic Chronic al the existence healthcare with the aim of Healthcare (document, interview, improving the quality of care. focus group, observation Review) 1.6 Social and HC VS 1.6.1: policies to promote Policies to Defined and User Need: Verification of the Policies coordination and/or Promote Implemented Organization existence (document, integration of social and Coordination  Especially for Frailty and al interview, focus healthcare have been of SC and HC Dependence group, observation defined and implemented, Policies to User Need: Review) especially in cases of frailty Promote Organization and dependence. Integration of al SC and HC

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4.4.2.1.2 Dimension 2: Community resources and policies Table 14 - Translation Table for the CCM Dimension 2.

DIMENSION 2: Behaviour Specification Value Specification: Value Attribute(s) System Type of Attribute/ Formative Evaluation Community User Expression Specification Requirement Resources and Policies 2.1 Community VS 2.1.1: programmes Designing Reflecting User Need: Service Verification of the strategies in health and community projects Programmes and Community Health existence (document, plans are designed reflecting Community Needs interview, focus community health needs. Projects group, observation Review) BS 2.1.2: institutions, Action: FBM: Green Dot+Path community agents, local Stakeholders work Behaviours bodies and the public Together work together with health institutions in planning community healthcare policies. 2.2 Alliances with VS 2.2.1: an up-to-date Mapping  Up-to-date User Need: Verification of the community map of community Community  Reflecting Resources Organizational existence (document, stakeholders resources that have an Resources that have impact on interview, focus impact on health has Health group, observation been developed and is in Review) and Use use. VS 2.2.2: partnership and Partnership and Through Agreements User Need: Verification of the cooperation agreements Cooperation between HC Organizational existence (document, are in place between providers and CR interview, focus healthcare providers and managers group, observation the management of Review) community resources. 2.3 Linking patients VS 2.3.1: channels for Meeting the Setting Up Channels User Need: Service Verification of the to community accessing community needs of Chronic for Accessing existence (document, resources. programmes and Patients Community interview, focus resources have been set Programmes and group, observation up to meet the needs of Resources Review) chronic patients.

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4.4.2.1.3 Dimension 3: self-management support Table 15 - Translation Table for the CCM Dimension 3.

DIMENSION 3: Behaviour Value Specification: User Expression Value Attribute(s) of the System Specification Type of Formative Evaluation Self- Specification Value Attribute/ Management Requirement Support 3.1 Patient- VS 3.1.1: chronic patients are able to HC contact Patients Are Able to User Need: Verification of the centred care identify one professional who acts as their Person identify it Service existence (document, healthcare contact person in each care  In each Care Setting interview, focus group, setting. observation Review) and Acknowledgement by the patient SS 3.1.2: patients Functional Functional Test have a contact number to obtain a device from a healthcare professional on a 24- hour basis (other than emergency services). VS 3.1.3: a specific action plan has been Specific Reflecting Values User Need: Verification of the devised for advanced chronic patients in Action Plan and Preferences Organizationa existence (document, the last stages of their life, reflecting their for l interview, focus group, values and preferences. Terminally observation Review) Ill Chronic Patients VS 3.1.4: an aim of the social care and Keeping  Supported by HC User Need: Verification of the healthcare provided is for patients to patients in and SC Organizationa existence (document, remain in their environment and in the their  With the best quality l interview, focus group, community with the best quality of life environme of life possible observation Review) possible. nts 3.2 Professional VS 3.2.1: professional healthcare Manageme Through User Need: Verification of the Competences competencies required for the nt of Development of Service existence (document, Related to management of chronic patients have Chronic Specific interview, focus group, Chronic Care. been established and are developed. Patients Professional observation Review) and Competencies Nr. Of Cases VS 3.2.2: certain professionals are given Coordinati Giving this role to User Need: Verification of the the role of ensuring coordination and on and certain Service existence (document, continuity of care, particularly in processes Continuity Professionals interview, focus group, of transition between care settings and of Care  Particularly in the observation Review) and

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planning hospital discharge. transition between Nr. Of Cases care settings and hospital discharge VS 3.2.3: nurse community case managers Manageme Involving Nurse User Need: Verification of the are involved in the management of high- nt of high- Community Case Service existence (document, risk chronic patients. risk chronic Managers interview, focus group, patients. observation Review) and Nr. Of Cases VS 3.2.4: competencies of professionals Emotional Relational Skills User Need: Verification of the are developed, in particular for relational Support  Behavioural Change Service existence (document, skills and skills for motivating patients for Skills interview, focus group, change observation Review) and Nr. Of Cases 3.3 VS 3.3.1: work is carried out in teams in ? Teamwork In User Need: Verification of the Multidisciplinary hospitals and other settings. hospital and other Organizationa existence (document, teamwork settings l interview, focus group, observation Review) and Nr. Of Cases BS 3.3.2: formal Action: FBM: Green Dot+Path and informal Stakeholders Behaviours relationships work between Together professionals with joint activities in different healthcare levels are encouraged. VS 3.3.3: teamwork between (health, social Improved Teamwork between User Need: Indicators (?).Verification and community) organisations is facilitated Planning health, social and Organizationa of the existence to improve planning, implementation and Improved community l (document, interview, improvement of care models for chronic Implement focus group, patients. ation observation Review) Improveme nt of Care Models VS 3.3.4: healthcare teams and other Shared Among User Need: Verification of the groups involved in patient care in other Goals professionals Service existence (document, settings treating the same chronic patients treating the same interview, focus group, have shared goals patients observation Review) and Nr. Of Cases

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3.4 Integration VS 3.4.1: pathways between primary and Pathways  For the most User Need: Verification of the and Continuity specialist care have been designed and put between common conditions Service existence (document, of Care into place for the most common chronic Primary  Describing route interview, focus group, conditions. These pathways describe the and and appropriate care observation Review) and route patients should follow and Secondary settings nr. Of cases appropriate healthcare settings based on Care  Based on Patient patient needs. _Needs VS 3.4.2: care processes take into account Defining Taking into account User Need: Verification of the the relationship with social care and the and social care and Service existence (document, community setting. Applying community settings interview, focus group, Care observation Review) VS 3.4.3: the integrated and Processes For Patients with User Need: Verification of the multidisciplinary care process for patients Multiple Conditions Organizationa existence (document, with multiple conditions is defined and are integrated and l interview, focus group, applied. Multidisciplinary observation Review) and nr. Of cases SS 3.4.4: alert Functional Functional Test systems are in place for informing and activating the clinical team during referral processes and transitions of care (hospital admission and discharge). VS 3.4.5: an alternative route, avoiding Alternative Avoiding emergency User Need: Verification of the attendances to the emergency Routes for attendances Service existence (document, department, has been established for poor  Online interview, focus group, chronic patients during periods of poor control or Consultations and observation Review) and control or worsening of their condition: on- worsening Phone contact nr. Of cases. line consultations, telephone contact; day  Day Hospital hospital; and admission, where necessary,  Managed from managed from the primary care setting. Primary Care Settings, where necessary. VS 3.4.6: medication reconciliation is Performing Performed Across User Need: Verification of the performed across the continuum of care, Medication Continuum of Care Service existence (document, and especially during transitions between Reconciliati During Transitions interview, focus group, different settings. on between settings observation Review)

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3.5 Active VS 3.5.1: standardised plans of action are Standardis For each Patient User Need: Verification of the Patient Follow- in place for each patient profile, including ed and Profile Service existence (document, up health promotion activities, preventative Personalize Health Promotion interview, focus group, measures and other interactions in the d Plans of Activities observation Review) integrated care process. Action  Preventative Measures  Interactions in the Integrated Care Process SS 3.5.2: a Functional Functional Test comprehensive care plan for each patient, with objectives for prevention, clinical control and symptoms control and self- management, is recorded in his/her medical record. SS 3.5.3: alerts have Functional Functional Tests been set up in the information system to make professionals aware that a patient’s condition has become poorly controlled. VS 3.5.4: patient medication is Detect and Through Systematic User Need: Verification of the systematically reviewed to detect and Address Review of Patient Service existence (document, address any efficacy, safety or adherence Efficacy, Medication interview, focus group, problems Safety and observation Review) and Adherence nr. Of cases

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3.6 Innovation in SS 3.6.1: technology Usability&UX Usability & UX Tests interactions is used to allow between remote interaction patients and between patients healthcare and professionals. professionals SS 3.6.2: Functional Functional Test telemonitoring or teleconsultation is commonly used to monitor/follow-up patients. SS 3.6.3: websites, Service and and Usability & UX Tests social networks, and Usability&UX blogs with health education content are promoted. SS 3.6.4: structured Functional Functional Test and proactive programmes are in place for remote monitoring/follow-up of chronic patients. VS 3.6.5: group sessions are held. Holding Group User Need: Verification of the Sessions Service existence (document, interview, focus group, observation Review) and Nr. Of Cases 3.7 Clinical VS 3.7.1: healthcare teams have powers to Teams are In terms of User Need: Verification of the management of manage their own resources, organisation Independe Resources, Organizationa existence (document, chronic and operation. nt Organization and l interview, focus group, conditions and Operation observation Review) incentive VS 3.7.2: an incentive scheme for Incentive Rewarding effective User Need: Verification of the schemes professionals is in place that rewards Schemes management of Organizationa existence (document, effective management of chronic patients. for patients l interview, focus group, Profession observation Review) and als Nr. VS 3.7.3: feedback of information is Improve Through feedback User Need: Improved Practice. routinely provided to clinicians so that they Practice of information Service Verification of the can improve their practice routinely provided existence (document, interview, focus group, observation Review)

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4.4.2.1.4 Dimension 4: delivery system design

Table 16 - Translation Table for the CCM Dimension 4.

DIMENSION 4: Behaviour Value Specification: User Expression Value Attribute(s) of the System Specification Type of Action/ Formative Evaluation Delivery Specification Value Attribute/ System Requirement Design 4.1 Patient VS 4.1.1: professionals perform a Identifying Comprehensive User Need: Service Verification of the assessment comprehensive assessment of each case, Needs, Assessment of existence for self- together with the corresponding patient, Attitudes and Cases (document, management to identify the patient’s needs, attitudes Self-mgmt. Together with interview, focus and skills for self-management. Skills Patient group, observation Review) and Nr. Of Cases VS 4.1.2: professionals evaluate the Identifying Through Evaluation User Need: Service Verification of the environment of each patient with limited Caregivers of the Patient’s existence autonomy (family and social network, Able to environment (document, workplace, etc.), together with the provide (Family, Social interview, focus corresponding patient, to identify Support Network, workplace, group, observation caregivers and their ability to provide the Patients with etc.) Review) necessary support Limited Together with the Autonomy patient 4.2 Structured VS 4.2.1: therapeutic education is Providing Covering all aspects User Need: Service Verification of the therapeutic provided to patients covering all aspects of Therapeutic of Chronic existence education their chronic condition, through structured Education Condition (document, programmes. Through structured interview, focus programmes group, observation Review) and Nr. Of Cases VS 4.2.2: various types of therapeutic Provided according User Need: Service Verification of the education are provided according to each to needs and existence patient’s needs and preferences: individual preferences (document, appointments, group sessions, telephone (individual interview, focus calls, emails, specialised websites, on-line appointments, etc.) group, observation courses, educational material, etc. Review)

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4.3 Psycho- VS 4.3.1: management skills of patients Increasing Problem Solving User Need: Service Increased social (for problem-solving, decision-making, Confidence Decision Making Confidence and development and proper use of healthcare and social and Motivation Proper Use of HC Motivation Regarding of patients and resources, among others) are developed for self-care and SC resources Self-care ability mutual support to increase their confidence and ability motivation with regard to their self-care ability (expert patient programmes). VS 4.3.2: emotional support is provided by Emotional By Patient and User Need: Service Verification of the patient and caregiver support groups support is Caregiver support existence provided group (document, interview, focus group, observation Review) BS 4.3.3: the Action: Caregivers FBM: Green participation of and Patients are Dot+Path Behaviours patients and encouraged to caregivers in participate associations, working groups, social networks and patient forums is encouraged.

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4.4 Tools to SS 4.4.1: patients have Usability&UX Usability & UX Tests facilitate self- clear, useful written management information regarding their personal care plan. SS 4.4.2: patients have Functional Functional Test secure electronic access to “personal health folders”, a part of their medical record that contains comprehensive information related to their condition (diagnosis, treatment, lifestyle recommendations, etc.). SS 4.4.3: self- Usability&UX Usability & UX Tests management tools (telephone contact, remote monitoring, patient notes, alerts, devices for measuring biological parameters, pill boxes, etc.) are used as appropriate for each patient. VS 4.4.4: programmes of group activities Fostering Through Group User Need: Service Verification of the fostering personal autonomy and patient Personal Activities existence health have been set up. Autonomy and (document, Health interview, focus group, observation Review) 4.5 Shared VS 4.5.1: patients receive clear, detailed, Patients are Clear, detailed, User Need: Service Verification of the decision- relevant information about their health well informed relevant information existence making problems and the various care options. about health (document, problems and interview, focus options group, observation Review) VS 4.5.2: patients are involved in defining Patient are In defining problems User Need: Service Verification of the problems, in the action plan for negotiating involved and action plans existence priorities and objectives, and in evaluating Negotiate priorities (document, their own progress. and objectives and interview, focus evaluating progress group, observation Review)

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4.4.2.1.5 Dimension 5: decision support

Table 17 - Translation Table for the CCM Dimension 5.

DIMENSION 5: Value Specification: User Value Attribute(s) of the Value Requirement Type of Formative Evaluation Decision Expression Attribute/ Support Requirement 5.1 Protocols VS 5.1.1: clinical practice Clinical Practice Covering Various Care User Need: Verification of the and shared guidelines covering the Guideline Settings and Sources of Service existence (document, guidelines various care settings and Knowledge interview, focus group, other sources of expert Used and Updated observation Review) and knowledge (decision- Nr. Of Cases making tools, etc.) are used and systematically updated. SS 5.1.2: algorithms for alerts and decision Functional Functional Test making, e.g., diagnosis and point-of-care clinical decision support related to therapeutic interventions, based on clinical practice guidelines, are included in patient medical records. VS 5.1.3: the design of Guidelines Covers most comorbidities User Need: Verification of the guidelines, protocols and Protocols and Service existence (document, expert tools covers the Expert Tools interview, focus group, most common types of observation Review) comorbidity

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5.2 Continued VS 5.2.1: the impact on Evaluation of on the Management of User Need: Impact on Practice education and practice of training Training Patients and Conditions Organizational training programmes on the Programmes management of chronic patients and chronic conditions is evaluated. 5.3 Liaison and VS 5.3.1: face-to-face Face-to-face Clinical Sessions, User Need: Verification of the consultation interaction (clinical Interaction Consultations between Service existence (document, sessions, consultations among professionals, rotations, etc. interview, focus group, between professionals, professionals used for exchange of observation Review) rotations, etc.) is used for knowledge and expertise the exchange of knowledge and expertise. SS 5.3.2: remote interaction (electronic Usability&UX Usability & UX Tests referral of patients, referrals via e-mail, referral via on-line platforms) is used for the exchange of knowledge and expertise.

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4.4.2.1.6 Dimension 6: clinical information system

Table 18 - Translation Table for the CCM Dimension 6.

DIMENSION 6: Value Specification: User Expression Value Attribute(s) of the System Specification Type of Formative Evaluation Clinical Information Value Attribute/ Systems Requirement 6.1 Information for SS 6.1.1: the risk classification of Functional Functional Test management and patients in terms of their expected care clinical practice requirements is included in their health record. SS 6.1.2: patient lists can be compiled Functional Functional Test and activities planned by health problem, risk level or other relevant clinical parameters. VS 6.1.3: clinical indicators have been Clinical Assessing User Need: Verification of the established to assess different Indicators are multidimensional Service existence (document, dimensions related to chronic established aspects of chronic interview, focus conditions: expected prevalence, level condition group, observation of diagnosis, level of control, suitability Prevalence Review) of treatment and adherence, use of Level of Diagnosis hospitalisation and emergency Level of Control services, complications and mortality. Suitability of Treatment and Adherence Use of Hospitalization and Emergency Services Complications and Mortality SS 6.1.4: processed data on indicators Service and and Functional Test are provided to clinicians and managers Functional on a regular basis to improve practice and management. SS 6.1.5: the medical record is designed Usability&UX Usability & UX Tests to be user-friendly and ergonomic in order to facilitate clinical monitoring by professionals 6.2 Integration of SS 6.2.1: the electronic health record Organizational and Functional Test patient clinical data can be accessed and updated by all and Functional care areas.

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SS 6.2.2: systems are in place to ensure Functional Functional Test the unequivocal identification of patients. SS 6.2.3: patients can enter clinical Functional Functional Test information (symptoms, adherence, data from occupational health check- ups or private healthcare, etc.) in their personal health folders within their health record. SS 6.2.4: information generated in Organizational and Usability & UX other sectors (social services, public and Usability&UX Tests health) is shared between professionals. 6.3 Reporting of SS 6.3.1: an e-referral or online Organizational and Functional Test clinical information consultation between professionals and Functional between from different healthcare areas with professionals. electronic exchange of information is in place. SS 6.3.2: a channel (direct phone line, Service and and Functional Test mobile or other means of contact) is in Functional place for consultations between professionals in real time across the various levels of care.

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4.4.3 Evaluation Cycle

The evaluation cycle is a description of:

. how to set up and verify the operationalization activities needed to deploy the intervention; . how to monitor, exploit and disseminate the results of the intervention.

In this case, the Operationalization, Monitoring and Dissemination activities set out in the Scaling-up strategy, have been used, while the CeHRes Operationalization and Summative Evaluation phases have been “embedded” in them, as shown in Figure 45.

Figure 45 - Innovation Assessment Flow.

4.4.3.1 Operationalization According to the Scaling up strategy of the EIP on AHA, the following stages have to be executed for individual scaling up of an innovation and, for this reason, they are used in the operationalization step of the evaluation cycle:

. Planning the innovative service and setting up a system for change . Organisational process and design choices

The CeHReS Roadmap, in the operationalization phase, states the following: planning and actions for dissemination, adoption and incorporation or internalization of the innovation are carried out. The operationalization plan consists of activities and resources for training, education, financing the operationalization to enable the use of the solution in daily practice by the end-users. Disregarding these conditions may limit the technology’s usefulness and delay decision-making. During the development process key stakeholders have to decide the strategies and activities for the operationalization of the innovation.

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Table 19 - Checklist activities to be assessed before implementing an innovation (source: extracted from the ScalingUpPaper).

Planning the innovative service & setting up a system for change Identifying The real needs that the innovation will serve are identified Needs and a strategic implementation plan is consequently defined. Securing Committed leadership from central and local authorities is Political present Support Establish multi- Multi-sectorial stakeholders’ alliances, ecosystems, stakeholder multidisciplinary teams, new relationships, agreements, collaboration bottom-up initiatives, “narratives beyond cost containment” are present. Configuring Shared-risk model, risk and reward share, rental of Business and technology system, self-financing, etc. Reimbursement Model Securing Financial support (e.g.: dedicated budget, standardization Financial of procurement, fund-raising organizations) is secured Support Organisational process and design choices Training and Education of care professionals and citizens is essential Re-skilling the (e.g.: national/regional/local training strategy, redesign or Workforce definition of new roles Technical 1) ICT solutions are best developed through active user support and involvement in the development phase. It is fruitful to have troubleshooting both the ICT provider and the care provider contributing human resources in developing the service platform. 2) Dedicated resources are required to develop and incorporate the technical solutions as part of the daily practice, as well as organise and manage the new service. 3) It is essential to have a team available for continuous development of services and for upgrading the services when new technological possibilities arise. Service re- Organisational processes, both clinical and administrative, design and have to be clearly defined and shared among stakeholders. organizational A common intervention plan and agreement for the new changes services, shared among all the care professionals involved (either from the health care or social care side) is at the foundation.

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4.4.3.2 Monitoring the Impact The CeHRes Summative Evaluation checklist provides a list of indicators to be used for uptake (Table 20) and impact (Table 21 and Table 22) assessment.

Table 20 - KPIs to be measured by the project management team, in order to assess the uptake of the innovative intervention (source: the CeHRes Roadmap list of Uptake Indicators).

Uptake Description KPIs User . Socio-demographic characteristics Profiling . Health-related characteristics . Context-related characteristics Usage . Frequency of use of the system’s features and Behaviour functions (monthly number of log-ins) . Continued use: extensive and repeated use of the eHealth application until the end of the study period (for example 2 years) . Discontinued use: stopped use of the eHealth application before the end of the study period (search for usage patterns) . Compliance with healthcare advice delivered via eHealth User . Reasons for (sustained) use: purpose of use and Motivations satisfaction (related to features & functions) . Reasons for non-use attrition (e.g., inappropriate information, wrong participants, ease of stopping to use it, lack of push factors, lack of personal contact, lack of positive feedback, lack of observable advantages, intervention has not been paid for, competing interventions, external events, no peer pressure, lack of experience of the user, workload and time required is too much).

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Table 21 KPIs to be measured by the project management team, in order to assess the impact on healthcare delivery (source: the CeHRes Roadmap list of Impact Indicators).

Uptake KPIs Description Increased . increased availability (healthcare at all times) access . increased possibilities (healthcare is provided in many forms) . improved equity (healthcare is available for everyone) Increased . reduced utilization of (unnecessary) health care efficiency services . time savings via substitution of tasks . improved communication between healthcare professionals . easier handling of healthcare equipment (e.g., guidelines) . reduced healthcare costs Increased . error reduction safety Increased . care delivery based on standards as guidelines - transparency protocols for information exchange Improved . more continuous feedback interaction . between caregivers and patients . among caregivers . among patients . Improved patient-caregiver relationship Improved . Increased adherence to guidelines or protocols. care delivery . Decision support . Increased satisfaction with care delivery

Table 22 KPIs to be measured by the project management team, in order to assess the impact on patient health&wellbeing.

Uptake KPIs Description Improved . Dietary values, HbA1c, blood pressure, etc. clinical values . Decreased mortality . Decreased morbidity Improved . social functioning, general or mental health, well- quality of life being Improved . change in attitude and increased knowledge, lifestyle (self- behavioural intention, and actual behaviour care) behaviour . improved compliance with advice: patient’s adherence to treatment . improved disease control: increased ability to control disease via self-monitoring, education, personal feedback

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The MAFEIP tool is used to perform a cost-effectiveness analysis of the intervention. The KPIs are listed in Table 23.

Table 23 KPIs to be measured by the project management team, in order to assess the impact on cost-effectiveness.

Uptake KPIs Description Cost- . incremental cost and health-related quality of life effectiveness per age-gender combination in the target population; . average per person incremental effects; . population level impact; . Impact of the intervention on the probability of the patient specified in the input environment to reside in each of the model states.

4.4.3.3 Disseminate Once the assessment is completed, the intervention needs to be classified and shared with the community.

The scaling up strategy offers tools to qualify, peer-review, store and share innovative practices.

Once it is described, it can be stored in the repository innovative practices and eventually be transferred to the community. A taxonomy has been provided, to this aim. The categories are the following:

1. Promising practices: practices that are not yet fully mature but have shown interesting first results. They are entirely based on the self-assessment of these results by the owner of the practice.

2. Notable practices: practices that have been deployed, have shown viability on international, national, regional or local levels and there is some evidence that supports this.

3. Good practices: practices that are deployed and that have shown full deployment, viability and transferability.

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4.4.4 Framework Consolidation.

The framework was first discussed on an individual basis. A document written as an executive summary was delivered to 2 groups of experts, one in the biomedical engineering domain and one from the system analyst domain, as in this phase the most important aspect was to understand if the procedures and transformations were properly realized. For this reason, the document described how the framework was built and for which purpose. The following comments were received. Table 24 describe the comments and how they were addressed.

Table 24 - Feedback gathered from the 1st round of individual discussions.

Description of the Comment How it has been addressed Expert n. 1 The work is complex but New descriptions have been provided, (biomedical ambitious. A huge effort need putting effort in using clear terms, engineer, to be done in terms of definitions and descriptions. system simplification. Examples analyst) would help. Not clear the need of concept The suggestion was followed: concept maps and ontologies at the maps are used as main formalism, some same time. One is enough. As definition from ontologies were used (e.g. an alternative, concept maps actions, predicates, concepts) can be used as most suitable formalism, while only the main concepts from ontologies can be “borrowed” Not clear how an ordered Literature research and summer school hierarchy can specify how to on HTA helped to clarify the best usage implement an improvement of the hierarchy, that is, a mean to stimulated constructive discussions among expert first, and then among end- users (i.e.: managers-healthcare team, patient-provider) More emphasis on the Strengthen the study of multidisciplinary concept of communicating research teams, to understand how requirement requirement should be used and communicated to each stakeholder. Careful selection of the case Literature search on Case Study and final study, in order to assess the selection of a Participant Observation real value of the framework Case Study. Expert n.2 Not clear the role of the CCM: A more rigorous description of the (biomedical is it the only model used or the Knowledge Translation Process and a engineer, framework is for all CC models clear distinction between the KTP and healthcare in general? the execution through the methods, in manager) order to clarify the role of the CCM: this is the selected input for the KTP, in the future other models can be used or selected by other researchers, without compromising the scientific soundness of the process that lead to the development of the framework. More emphasis to all the Improved description of innovations and spectrum of innovation, not of the Research Objectives and Research only IT Hypotheses 157

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The framework was then presented in the form of a lecture during a summer school organized by the IEEE EMBS, the 2nd IEEE EMBS Summer School on Emerging Technologies and Applications in Telemedicine 25. 9 PhD students, 4 distinguished professors (two of them offered to be involved in the 2nd round of validation) assisted to a 3 hour explanation of the framework. The comments gathered are described in Table 25.

Table 25 - Feedback gathered from the focus group.

Description of the How it has been addressed Comment The background Objective of the lecture was to test the solidity of the information used to background information so, the emphasis on build the framework is explaining these element was done on purpose. interesting but very vast. Attention to be paid to The translation tables have been readapted and make the framework simplified, as well as separated in separate tables for less complex each group of stakeholder. Is the framework too The requirements specifications should be used to rigid? stimulate bottom-up thinking Similar tools in This element has been included in the discussion certifying Gov. mgmt. section. Of IT (COBIT 5) Create a Web This element has been included in the discussion section. How are you This element was not ready when presented in the retrofitting evaluation focus group. New figures a better description of the cycle feedback to the evaluation cycle has been provided, with a list of KPIs previous cycles? for each element of the innovation and, as such their link to previous development cycle is clearer.

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Result 3: a mixed-method approach to evaluate multidisciplinary teams innovating for improving CDs

The mixed-method approach suggested by Wooten et al. to evaluate MTTs working in translational health (Wooten et al., 2013) was further elaborated, in order to have an instrument to evaluate MTTs working in the translation of applied healthcare research.

The mixed-method is described in Table 26:

. the descriptive component of the framework - which, by definition, represent the translation of an evidence based healthcare result (the CCM) into a structured description of goals, needs, specifications and KPIs in a domain (eHealth) that should serve as a catalyst for innovation – was merged with the mixed-method approach of MTT, in order to define the stepwise procedures that have to be executed in order to evaluate a multidisciplinary team that makes use of the framework, . The approach suggested by the HTA core model® has been used to create quantitative instruments to be delivered to the expert panel that are synthetic and complete at the same time. Experts are requested:

1. to rate an element (i.e. a healthcare improvement in the design cycle, a behaviour, a value or a system specification in the implementation phase) 2. to provide the source where the presence of this element is described, as HTA agencies do when reporting on medical device s.

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Table 26 - Evaluation factors used to evaluate the Case Study (modified from Multidisciplinary Translational Teams).

Nr. Innovative Methods used Qualitative or Type Team intervention Quantitative Involved factors 1. Innovative Artefacts (scored grant Qualitative Outcome Coordina intervention application, review reports) tion plan 2. Design cycle – Artefacts (stakeholder Qualitative Outcome Coordina description description, completion of and tion formal milestones; quantitative accomplishment of short/medium/long term outcomes, time and resources utilization) 3. Design cycle – HTA-based process Quantitative Outcome All teams healthcare Survey improvements hierarchies 4. Implementation Artefacts (completion of Qualitative Outcome All teams cycle – formal milestones; and description accomplishment of quantitative short/medium/long term outcomes, time and resources utilization) 5. Behavioural HTA-based process Quantitative Process Human specifications Survey and factors Developme team ntal 6. Values, HTA-based process Quantitative Outcome, Domain attributes and Survey Process and system and develop specifications Developme ment ntal leaders 7. Evaluation cycle Artefacts (completion of Qualitative Outcome Coordina – description formal milestones; and tion accomplishment of quantitative short/medium/long term outcomes, time and resources utilization) 8. Operationalizati Artefacts (Training, socio- Qualitative Process Coordina on economic analysis, and tion and business Modelling) Developme domain ntal 9. Uptake Uptake KPIs Quantitative Outcome Coordina tion 10. Impact Impact KPIs Quantitative Outcome Coordina tion 11. Cost- Cos-effectiveness analysis Quantitative Outcome Coordina effectiveness (MAFEIP tool) tion 12. Dissemination Bibliography (articles, Qualitative Process Coordina patents, grants obtained, and tion and innovative practice Developme domain category) ntal

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In order to use this instrument, the innovative project need to be described, may be this an already approved grant or a project proposal. Documented descriptions of the design, implementation and evaluation phases are also needed. With this conditions achieved, an expert panel can be set up to evaluate the innovation process. The expert panel will rate the design and implementation phases using HTA-based surveys. An example is provided here for the Design Phase (assessing HC improvements), while the full list is provided in Annex 5. Experts are requested to rate, from 0 (not present) to 3 (high), the presence of an element (e.g. a healthcare improvement in the design cycle, a value specification in the implementation phase).

Table 27 – Excerpt from the Questionnaire used to evaluate the design phase of the innovation against the CCM HC improvements.

Please rate the following elements by answering to the following question: “Did [Name of the Project] designed solutions or defined the conditions to cover the following needs for Patient Activation?” . 0 = not present, . 1 = low, . 2 = medium, . 3 = high. Patient Activation BELIEFS: The She/he is HC An ACTIVE project has RESPONSI professional ROLE worked in BLE for s are not the determines creating in the managing main actors wellbeing patient’s mind health the BELIEF that:

Table 28 – Excerpt from the Questionnaire used to evaluate the implementation phase of the innovation against the CCM Interventions (in this case, Values, Attributes and System Specifications of the component 1.2 – Strategic Framework).

Please rate the following table: 0 = not present, 1 = low, 2 = medium, 3 = high. 1.2 Strategic Framework Value Specification Is the project Is the project defining this verifying this value? value? (Document source, (Document reference, Work source, Package) reference) Value Attribute(s) 1.2.1 Strategic Systematic Vision Approach to CC Developed with Stakeholders in Place Bringing values, quality and (organizational) responsible use of resources

Value Attribute(s) 1.2.2 Measurable Definition and Objectives Dissemination in the (organizational) relevant settings System Specification 1.2.3 System for monitoring strategic planning (process and outcomes) in chronic care is in place. Organizational and Functional.

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Result 4: validation of the framework

In this section, the validation of the framework through the case study experiment is provided. As regards the project artefacts, used to execute the steps enlisted in Table 26, they were taken from the official documentation of the METABO project. These are:

. Evaluation Summary Report (METABO, ESR, 2007) . Grant Agreement (METABO, Annex I, 2008) . Periodic Management Reports (PMR1, 2009 ; PMR2, 2010; PMR3, 2011; PMR4, 2012) . Technical documents (Deliverables ) reporting on:

 Pilot Activities (METABO Deliverable D4.2, 2012)  Business Plan (METABO Deliverable D8.5, 2012)  Organizational Aspects (METABO Deliverable D7.4, 2012)

As mentioned in section 3.1.4, the validation of the framework has been done both in a retrospective and a prospective fashion: the design and implementation phases of the project (2008-2012) were already finalized, while the evaluation phase started on 2012 and is still ongoing and the study has reported on how the framework has influenced the design and implementation phases of new cycles of the innovation. In a nutshell, the following activities have been carried out:

. Qualitative analysis of the project artefacts to describe the results achieve by the project in the different stages, following the procedures of Table 26, . Quantitative evaluation of the project design and implementation phases via the Expert Panel. The following Expertise Dimensions were involved, through the collaboration of the project leaders (in parenthesis, their expertise is provided).

 Scientific Manager (Clinical)  Innovation Manager (Marketing and Business)  Healthcare Manager (Healthcare)  UI-Design Manager (Human Computer Interaction and Human Factors)  SW-Design Manager (System Analyst)  System-Design Manager (System Developer)

. Quantitative analysis of project results from the pilot activities, socio- organizational and business modelling analyses, using the KPIs defined in the framework. . Cost-effectiveness analysis through the MAFEIP tool (excerpts from the report provided to the EC have been used).

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. Classification of the intervention through the repository of the innovative practices of the EIPonAHA.

4.6.1 Case Study design

The following STAGES of evaluation have been defined (adapted and re- elaborated from Yin - Yin, 2010 - and synthesised in a web tutorial of the University of Texas37), and embedded with the mixed-method described in Table 26 :

Table 29 - Design of the Case Study.

STAGE 1: project description and identification of phases a. The innovation is described in terms of main objectives and key elements. The description is evaluated (point 1 of Table 26) b. The design, implementation and evaluation cycles of the case study are clearly identified. STAGE 2: framework configuration. a. It is determined whether the innovation a. has been/is being /will be, implemented b. at a macro/meso/micro level. if a macro intervention, the CCM dimensions will be evaluated in the order 1-2- 3-4-5-6. If not (i.e. meso and micro), the CCM dimensions will be evaluated in the order 3-4-2-1-5-6. b. It is determined which elements and components of the CCM are: a. directly related, b. indirectly related (i.e. they are contextual), c. not related (i.e. this means that they are excluded from the evaluation), with the innovation. STAGE 3: supporting the design cycle. a. The design cycle is described through point 2 of Table 26. b. The design cycle is analysed through point 3 of Table 26. STAGE 4: supporting the implementation cycle. a. The implementation cycle is described and evaluated through point 4 of Table 26. b. The implementation cycle is analysed points 5 and 6 of of Table 26. STAGE 5: supporting the evaluation cycle. a. The evaluation cycle is described and evaluated through point 7 of Table 26. b. The evaluation phase is analysed through points 8, 9, 10, 12 and 12 of Table 26. STAGE 6: reporting. a. A report is issued, to refine the framework, describing the way it should be delivered to end-users, as well as future improvements and research work.

37 https://www.ischool.utexas.edu/~ssoy/usesusers/l391d1b.htm 163

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4.6.2 STAGE 1: project description and identification of phases.

a. The innovation is described in terms of main objectives and key elements. The description is evaluated (point 1 of Table 26)

Nr. Innovative Methods used Qualitative/ Type Team Involved intervention quantitative factors 1. Innovative Artefacts (scored Qualitative Outcome Coordination intervention grant application, plan review reports)

The METABO project aimed at developing innovative, ICT-based, solutions for the management of diabetes, to be delivered to both patients and professionals. A consortium composed of 21 partners representing hospitals, healthcare agencies, healthcare industries, SMEs, and research academies, worked together for about 4 years to define these solutions and eventually test them in pilot studies. The work was organized in 5 Subprojects and 16 Work Packages (figure). About 11M€ and 1000 Person Months were needed to implement project activities.

The project was funded under the 7th Framework Programme (2007-2013) of the European Commission, under the topic Personal Health Systems of the ICT programme. It was scored 11.5/5 (METABO Evaluation Summary Report, 2007):

. 3.5/5 under the category Scientific and/or technological excellence: it was recognized the advance with respect to SoA in terms of mobile patient monitoring and of the well justified medical methodology, while some concerns about lack of details for medical device interoperability, and how to address difference among European dietary patterns . 4/5 under the category Quality and efficiency of the implementation and the management: the project management, financial and technical structures were good, however the role of some partner was not clearly fitting with the project tasks. . 4/5 under the category potential impact through the development, dissemination and use of project results: some concerns about proprietary developments and liability issues that could jeopardize the impact of the project, while the other dimensions were positively rated.

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b. The design, implementation and evaluation cycles of the case study are clearly identified.

The project execution was organized in 4 periods or phases (METABO Grant Agreement, 2008). For each Period, project milestones were defined, they are described below:

1. Project Inception and Design (M1-M12):

. Milestone 1: All management mechanisms are in place, including quality control, risk management, internal communications and reporting. . Milestone 2: All information needed to start implementation work has been collected: implementation work can start.

2. Project Implementation (M12-36):

. Milestone 3: System requirements and all information needed to start the validation activities are available; overall validation strategy has been defined and the protocols/indicators refinement process is already in place. The implementation work and the fine tuning of the scientific activities can start. . Milestone 4: Market survey completed. Initial internal IPR agreement reached. Business model defined. Full exploitation activities can start. . Milestone 5: The integration of an initial version of METABO Platform can be started.

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3. Project Pilot (M36-48):

. Milestone 6: All METABO Platform components and functions are completed: full integration can start. Pilot Experience can continue on a reduced version of the Platform. . Milestone 7: Pilot Experience can continue on the full METABO Platform . Milestone 8: METABO Platform fully validated. . Milestone 9: Socioeconomic, organizational and ethical guidelines available. . Milestone 10: Launch of the METABO paradigm can start.

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4.6.3 STAGE 2: framework configuration.

a. It is determined whether the innovation a. has been/is being /will be, implemented b. at a macro/meso/micro level. if a macro intervention, the CCM dimensions will be evaluated in the order 1-2-3-4-5-6. If not (i.e. meso and micro), the CCM dimensions will be evaluated in the order 3-4-2-1-5-6.

Aim of the project was to develop innovative solutions for the management of type 1 and type 2 Diabetes Mellitus, to be tested in clinical settings (hospitals and ambulatories). Being an international project and planning multiple intervention across different healthcare settings, the assessment is considered as macro, and as such the elements of the CCM will be analysed in the 1-2-3-4-5-6 order.

In terms of timing: the project terminated on September 2012. However, during March 2012, the first round of commitments of the EIP on AHA started. The METABO project was therefore included as part of the commitment that UPM prepared for the A1 group. Therefore, the activities related to the assessment of the impact are ongoing and evolving within the EIP on AHA framework. To conclude, the first cycle of the Design and Implementation phases have finalized, while the evaluation phase is ongoing.

b. It is determined which elements and components of the CCM are directly, indirectly (i.e. they are contextual), or not (in this case they are excluded from the evaluation), related with the innovation.

In terms of CCM elements, the following ones have been discarded:

. VS 3.1.3: a specific action plan has been devised for advanced chronic patients in the last stages of their life, reflecting their values and preferences. . VS 3.4.6: medication reconciliation is performed across the continuum of care, and especially during transitions between different settings. . VS 4.1.2: professionals evaluate the environment of each patient with limited autonomy (family and social network, workplace, etc.), together with the corresponding patient, to identify caregivers and their ability to provide the necessary support

This because the METABO project was focusing on the management and stabilization of patients without the presence of advanced complications (i.e.: with disability and at later stage of the disease).

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4.6.4 STAGE 3: supporting the design cycle.

In this stage, project mission, objectives and challenges are analysed and compared against the 2 hierarchies of needs. Moreover, the stakeholders involved in the project are analysed.

c. The design cycle is described and analysed through point 3 of Table 26.

Nr. Innovative Methods used Qualitative/ Type Team interventi quantitative Involved on factors 3. Design Artefacts (stakeholder Qualitative and Outcome Coordination cycle – description, completion quantitative descriptio of formal milestones; n accomplishment of short/medium/long term outcomes, time and resources utilization)

According to the project 1st Year Periodic Management Report:

1. Stakeholder Analysis:

. Leaders

 The coordinator, the project manager, the scientific manager, the technical manager (participant and observer of the case study), the clinical partners and other key partners (i.e.: responsible of the definition of the clinical pathways, socio-organizational, business and innovation aspects)

. Health and Social Care Professionals, members of a HC team

 Clinical Partners provided of the project covered the following figures

o endocrinologists o diabetes-specialized nurses o diabetes-specialized educators o diabetes-specialized psychologists o diabetes-specialized nutritionists

. Informal Care Givers

 Informal care givers were not present as partners of the project.

o Patient Groups (forum, social, etc.) o Patient groups or association were not partnering the project

2. Milestones and outcomes (see Figure 47): management mechanisms were properly put in place and executed during this phase.

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As regards the technical activities, changes were needed to the user need elicitation phase, because, prior to this, the need to create a 10 years vision of the project (“METABO will be successful if a contribution and a real impact on the Diabetes Disease Management in Europe will be achieved in the next 10 years. This must be taken in mind during the development of the Project”), and a customer- based segmentation the diabetes population (Guillén, 2011), in order to better structure the User Requirements and Functional Specification activities, were identified.

This brought also to the definition of a new strategy (and a new Milestone) for the validation of the scientific activities which, were not foreseen validation activities (e.g.: data collection, patient profiling) stratified per patient group.

From the administrative point of view, however, one partner left the project from the very beginning and the UR&FS activities were reorganized among the other partners. This, together with the inclusion of the new milestone implied a contractual change to be reflected in Annex I of the Grant Agreement.

TABLE 2. MILESTONES

Milestone Milestone Due Achieved Actual / Comments name achievement Yes/No Forecast no. date from achievement Annex I date

1 Project March 2008 Yes Not All management mechanisms are in place, inception applicable completed including quality control, risk management, internal communications and reporting. 2 Requirement August 2008 Yes Not The milestone has been achieved by Month 8 since analysis and applicable System User Requirements and System Specifications are Specification being conducted Completed successfully. UR&FS Deliverables will be merged and sent after external revision 2bis Scientific February No 14 System requirements and validation 2009 all information needed to strategy start the validation available activities are available; overall validation strategy: has been defined (and the protocols/ indicators refinement process is already in place. The implementation work and the fine tuning of the scientific activities can start. The milestone will be achieved without deviations

Figure 47 - Milestones reached during the Design Phase (extracted from METABO PMR 1, 2009).

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b. The design cycle is analysed through point 4 of Table 26.

Evaluation factors used to evaluate the Case Study (modified from Multidisciplinary Translational Teams).

Nr. Innovative Methods used Qualitative/ Type Team intervention quantitative Involved factors 4. Design cycle – Artefacts Qualitative Outcome All teams healthcare (accomplishment improvements of healthcare hierarchies improvements via project management reports)

As regards point b, an HTA-based survey (described in Annex 5) was circulated to the following expert panels:

1. Scientific manager 2. Healthcare manager 3. Innovation manager 4. UI-design manager, 5. SW-design manager, 6. System-design manager.

The results are presented for the scientific, healthcare and business dimensions in Figure 48 and Figure 50, for UI, SW and development dimensions in Figure 49 and Figure 51, and together in Table 30 and

Table 31, while their interpretation is provided in STAGE 6.

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Healthcare Improvements for Patient Activation (0=not present; 1 = low, 2 = medium, 3 = high)

ON daily basis 3 2 2 AGAINST things one wants to do 2 2 2 during times of STRESS 3 1 2 The patient, will MANTAIN lifestyle changes 2,7 1,7 2,0

SELF-CARE 3 2 3 LIFESTYLE Management 3 2 1 DECISIONS 2 2 1 The patient is BEING PROACTIVE towards: 2,7 2,0 1,7

HEALTH CONDITION 1 2 2 SELF MANAGEMENT 3 3 2 CARE PLAN 3 3 2 The patient is being CONFIDENT AND… 2,3 2,7 2,0

An ACTIVE ROLE determines wellbeing 3 2 3 HC professionals are not the main actors 2 2 2 She/he is RESPONSIBLE for managing… 3 3 1 The patient has the BELIEF that: 2,7 2,3 2,0 0,0 1,0 2,0 3,0 4,0 5,0 6,0 7,0 8,0 9,0

Scientific Healthcare Business

Figure 48 - Overview of How the Expert Panel rated Patient Activation HC Improvements according to the Scientific, Healthcare and Business dimensions.

Healthcare Improvements for Patient Activation (0=not present; 1 = low, 2 = medium, 3 = high)

ON daily basis 3 3 3 AGAINST things one wants to do 3 2 1 during times of STRESS 2 2 0 The patient, will MANTAIN lifestyle… 2,7 2,3 1,3

SELF-CARE 3 3 3 LIFESTYLE Management 3 3 3 DECISIONS 2 2 2 The patient is BEING PROACTIVE towards: 2,7 2,7 2,7

HEALTH CONDITION 3 3 2 SELF MANAGEMENT 3 3 3 CARE PLAN 3 3 2 The patient is being CONFIDENT AND… 3,0 3,0 2,3

An ACTIVE ROLE determines wellbeing 2 3 3 HC professionals are not the main actors 3 3 2 She/he is RESPONSIBLE for managing… 3 3 2 The patient has the BELIEF that: 2,7 3,0 2,3 0,0 2,0 4,0 6,0 8,0 10,0

UI-Design SW-Design Development

Figure 49 - Overview of How the Expert Panel rated Patient Activation HC Improvements according to the UI-Design, SW-Design and Development dimensions.

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Healthcare Improvements for Practice Team (0=not present; 1 = low, 2 = medium, 3 = high)

SCHEDULING 3 3 3 COMMUNITYRESOURCES&INITIATIVE 2 3 1 REMOTE MONITORING 3 3 3 PROVIDING CONTINUOUS FOLLOW-UP 2,7 3,0 2,3

COACHING 3 3 1 THERAPEUTIC ALLIANCE 3 3 2 GOAL SETTING 3 3 2 IMPROVING SELF-MANAGEMENT 3 3 1,7

Working as a TEAM 2 2 3 Involving the PATIENT 3 3 1 Making use of CLINICAL GUIDELINES 2 2 2 CLINICAL-BEHAVIOURAL INTERVEN 2,3 2,3 2,0

The PATIENT EMPOWERMENT 3 3 1 The DATA ASSESSMENT 3 2 2 The TEAMWORK 2 1 1 The ORGANIZATION 2 1 2 Reviewing Data 2,5 1,8 1,5 0 2 4 6 8 10

Scientific Healthcare Business

Figure 50 - Overview of How the Expert Panel rated Care Team HC Improvements (Scientific, Healthcare and Business dimensions).

Healthcare Improvements for Practice Team (0=not present; 1 = low, 2 = medium, 3 = high)

2 3 3 COMMUNITYRESOURCES&INITIATIVE 3 3 0 3 3 3 PROVIDING CONTINUOUS FOLLOW-… 2,7 3,0 2,0 COACHING 3 3 3 3 2 3 GOAL SETTING 3 3 3 3 2,7 3 3 3 1 Involving the PATIENT 3 3 0 3 3 0 CLINICAL-BEHAVIOURAL INTERVEN 3,0 3,0 0,3 The PATIENT EMPOWERMENT 3 2 3 2 3 3 The TEAMWORK 3 3 3 2 3 3 Reviewing Data 2,5 2,8 3,0 0,0 2,0 4,0 6,0 8,0 10,0

UI-Design SW-Design Development

Figure 51 - Overview of How the Expert Panel rated Care Team HC Improvements (UI, SW and Implementation dimensions).

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Table 30 - Table view of Patient ACTIVATION HC improvements.

DIMENSIONS Scientific Healthcare Business Definition Design Develop Avg. PATIENT ACTIVATION The project has worked in creating in the 2,7 2,3 2,0 2,7 3,0 2,3 2,5 patient’s mind the BELIEF that: She/he is RESPONSIBLE for managing health 3 3 1 3 3 2 2,5 HC professionals are not the main actors 2 2 2 3 3 2 2,3 An ACTIVE ROLE determines wellbeing 3 2 3 2 3 3 2,7 The patient is being CONFIDENT AND 2,3 2,7 2,0 3,0 3,0 2,3 2,6 INFORMED about: CARE PLAN 3 3 2 3 3 2 2,7 SELF MANAGEMENT 3 3 2 3 3 3 2,8 HEALTH CONDITION 1 2 2 3 3 2 2,2 The patient is BEING PROACTIVE towards: 2,7 2,0 1,7 2,7 2,7 2,7 2,4

DECISIONS 2 2 1 2 2 2 1,8 LIFESTYLE Management 3 2 1 3 3 3 2,5 SELF-CARE 3 2 3 3 3 3 2,8 The patient, will MANTAIN lifestyle changes 2,7 1,7 2,0 2,7 2,3 1,3 2,1 during times of STRESS 3 1 2 2 2 0 1,7 AGAINST things one wants to do 2 2 2 3 2 1 2,0 ON daily basis 3 2 2 3 3 3 2,7

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Table 31 - Table View of Care Team HC Improvements.

DIMENSIONS

Scientific Healthcare Business Definition Design Develop Avg.

PROACTIVE AND PREPARED CARETEAM

REVIEW DATA WHEN MANAGING 2,5 1,8 1,5 2,5 2,8 3,0 2,3 CONDITION The ORGANIZATION 2 1 2 2 3 3 2,2 The TEAMWORK 2 1 1 3 3 3 2,2 The DATA ASSESSMENT 3 2 2 2 3 3 2,5 The PATIENT EMPOWERMENT 3 3 1 3 2 3 2,5 APPLY CLINICAL-BEHAVIOURAL 2,3 2,3 2,0 3,0 3,0 0,3 2,2 INTERVEN Making use of CLINICAL GUIDELINES 2 2 2 3 3 0 2,0 Involving the PATIENT 3 3 1 3 3 0 2,2 Working as a TEAM 2 2 3 3 3 1 2,3 WORK ON IMPROVING SELF- 3 3 1,7 3 2,7 3 2,7 MANAGEMENT GOAL SETTING 3 3 2 3 3 3 2,8 THERAPEUTIC ALLIANCE 3 3 2 3 2 3 2,7 COACHING 3 3 1 3 3 3 2,7 PROVIDING CONTINUOUS FOLLOW-UP 2,7 3,0 2,3 2,7 3,0 2,0 2,6 REMOTE MONITORING 3 3 3 3 3 3 3,0 COMMUNITYRESOURCES&INITIATIVE 2 3 1 3 3 0 2,0 SCHEDULING 3 3 3 2 3 3 2,8

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4.6.5 STAGE 4: supporting the implementation cycle.

a. The implementation cycle is described and evaluated through point 5 of Table 26.

Nr. Innovative Methods used Qualitative/ Type Team intervention quantitative Involved factors 5. Implementat Artefacts (completion of Qualitative and Outcome All ion cycle – formal milestones; quantitative teams description accomplishment of short/medium/long term outcomes, time and resources utilization)

The following milestones and outcomes (Figure 52) were reached during Period 2 (METABO PMR, 2010) and Period 3 (METABO PMR3, 2011):

1. Period 2: during the first months of this period, the EC experts provided their suggestions and reviews. The main message was that, in order to satisfy the new strategies and ambitions (Vision+Customer Segmentations) particular attention needed to be devoted to the business and development activities.

As regard the first ones, new indicators and business cases were to be defined according to the different scenarios and segments. As regards the second one, a User Centred Design approach needed to be adopted, in order to develop solutions that can be really used and accepted by end users in the real world. The EC experts asked an Interim Project Review, to show that that a functional version of the platform was running. The review was successful in delivering this outcome. From an administrative point of view, the amendment to the contract, that should have reflected the changes of period 1, took much more time than expected and this caused delays in payments, which affected also the work to be carried out. Additionally, in order to better address the User Centred Design strategy, a new partner with expertise on Human Factors was included.

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TABLE 2. MILESTONES

Miles Milestone Due Achieved Actual / Comments tone name achieveme Yes/No Forecast nt date achievement no. from date Annex I

2bis Scientific February Yes February 2009 System requirements and all validation 2009 information needed to start the strategy validation activities are available; available overall validation strategy: has been defined (and the protocols/ indicators refinement process is already in place. The implementation work and the fine tuning of the scientific activities can start. The milestone has been achieved without deviations

3 Business June 2009 Yes Draft The deliverables expected in modelling version on the period were delayed due to defined August, final the need to better identify and version define the exploitable outcomes achieved and to aggregate them into during marketable products (the December “METABO Editions”). 2009

4 Major September Yes September Major components were platform 2009 2009 implemented by componen September/October 2009. t have Some of them were refined, been according to User Iterative implement Processes (WP1.4 and WP3.3 ed mainly). Decision Support System need to be validate with real data expected from Pilot.

Figure 52 - Milestones Reached during the Implementation Phase.

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2. Period 3 (milestones shown inFigure 53): during this period major focus was given to the development and iterative refinement of the platform and of the applications to be used by professionals and patients in the final testbed. Usability tests, focus group interviews, heuristic evaluation activities, defined by the new partner, were implemented.

In parallel the collateral activities needed to set up the evaluation were implemented too: protocol definition and approval from the ethical committees of the centres, deployment plans, pilot end-users training activities.

In the meantime, some partners went under financial audit and, based on this, clarifications were asked by the EC financial authorities. In some cases the activities of some partners were suspended, this meant that the remaining work of this partners was to be implemented by others. This caused further delay and redistribution of project tasks among the partners. All these aspects led to complete the expected activities 9 months after the schedule.

Figure 53 - Milestones of the 3rd Period.

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b. The implementation cycle is analysed through the translation table, to observe if, and how, behaviours, values, attributes and system specifications are defined and accomplished (points 6 and 7 of Table 26).

Nr. Innovative Methods used Qualitative/ Type Team interventio quantitative Involved n factors 6. Behaviour Process Observations of Qualitative Process and Coordination al behaviour, interaction Developmen team, Clinical specificati patterns, tal team, ons Development team, Business and Innovation team 7. Values, Artefacts (annual Qualitative Outcome, Domain and attributes progress and Process and development and reports, meeting notes) quantitative Developmen leaders system HTA-based process tal specificati survey ons Formative evaluation- (progress specific method (as across listed in translational domains) table)

The expert panel teams was asked to rate if behaviours, values and system specifications were achieved, in particular:

. The scientific manager rated the behaviours of the project leaders and the values of dimensions 1 and 2 of the CCM. . The Healthcare managers rated the behaviours of all stakeholders, and the values of values of dimensions 3,4,5 and 6 of the CCM . The design, development and implementation leaders rated the behaviours of all stakeholders and the system specifications of all the dimensions (which are 4,5 and6 of the CCM) . The innovation leader rated the behaviour all stakeholders and the values of dimensions 1 and 2 of the CCM.

Results are presented in the following figures and tables, while their interpretation is given in STAGE 6 of the case study.

Each graph rate, for each specification, how they have been rated by the project leaders.

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The coordination team developed an explicit vision of Chronic Care. (0=not present; 1 = low, 2 = medium, 3 = high)

Was the decision properly communicated, made 2 3 1 3 2 3 understandable as an important… Was the decision interrupting an existing routine (e.g. breaking an 3 2 2 3 01 old habit) Was the decision unpopular for some group of people involved in 2 3 01 1 2 the project? Was the decision stimulated through a specific activity or tool 3 3 2 2 2 3 developed during the project?

Was the decision linked to project 3 3 1 2 2 3 meetings, event or workshop?

Was the leader triggered to perform this action at least in one 3 3 2 3 3 3 of the following ways…

Was the behavior adopted? 2 3 0 3 3 3

0 2 4 6 8 10 12 14 16 18 Was the leader triggered Was the Was the to decision Was the Was the decision perform Was the stimulate decision decision properly this decision d unpopula interrupti communi action at linked to through a r for ng an cated, Was the least in project specific some existing made behavior one of meetings activity group of routine understa adopted? the , event or or tool people (e.g. ndable as following worksho develope involved breaking an ways p? d during in the an old importan (convers the project? habit) t thing to ation, project? do? notificati on, stands)? Scientific 2 3 3 3 2 3 2 Healthcare 3 3 3 3 3 2 3 Business 0 2 1 2 0 2 1 UI Design 3 3 2 2 1 3 3 SW Design 3 3 2 2 1 0 2 Development 3 3 3 3 2 1 3

Scientific Healthcare Business UI Design SW Design Development

Figure 54 – Behaviours of Leaders: Did the Coordination Team develop a vision of Chronic (i.e.: Diabetes) Care?

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The coordination team: allocated resources to drive transformation of Diabetes Care with the aim of improving care for diabetic patients. (0=not present; 1 = low, 2 = medium, 3 = high)

Was the decision properly communicated, made 2 2 2 3 2 3 understandable as an important… Was the decision interrupting an existing routine (e.g. breaking an old 2 2 0 3 0 habit) Was the decision unpopular for some group of people involved in 2 2 0 1 2 0 the project? Was the decision stimulated through a specific activity or tool 2 3 2 2 2 3 developed during the project?

Was the decision linked to project 2 3 2 3 2 3 meetings, event or workshop?

Was the leader triggered to perform this action at least in one 2 3 1 2 3 3 of the following ways…

Was the behavior adopted? 2 3 0 3 3 3

0 2 4 6 8 10 12 14 16 Was the leader triggered Was the to Was the Was the Was the decision perform decision Was the decision decision properly this stimulate decision unpopula interrupti communi action at d through linked to r for ng an cated, Was the least in a specific project some existing made behavior one of activity or meetings group of routine understa adopted? the tool , event or people (e.g. ndable as following develope workshop involved breaking an ways d during ? in the an old importan (convers the project? habit) t thing to ation, project? do? notificati on, stands)? Scientific 2 2 2 2 2 2 2 Healthcare 3 3 3 3 2 2 2 Business 0 1 2 2 0 0 2 UI Design 3 2 3 2 1 3 3 SW Design 3 3 2 2 2 0 2 Development 3 3 3 3 0 0 3

Scientific Healthcare Business UI Design SW Design Development

Figure 55 - Behaviours of Leaders: Did the Coordination Team allocated resources to drive transformation of Diabetes Care?

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Senior leaders of the Clinical partners promoted clinical leadership among members of multidisciplinary teams. (0=not present; 1 = low, 2 = medium, 3 = high)

Was the decision properly communicated, made 1 2 3 1 understandable as an important…

Was the decision interrupting an existing routine (e.g. breaking an old 1 2 1 3 habit)

Was the decision unpopular for some group of people involved in 1 1 2 2 the project?

Was the decision stimulated through a specific activity or tool 1 3 2 1 developed during the project?

Was the decision linked to project 1 2 2 1 meetings, event or workshop?

Was the leader triggered to perform this action at least in one of 2 3 2 1 the following ways (conversation,…

Was the behavior adopted? 1 2 2 1

0 1 2 3 4 5 6 7 8 9 Was the leader triggered Was the to Was the Was the Was the decision perform decision Was the decision decision properly this stimulate decision unpopula interrupti communi action at d through linked to r for ng an cated, Was the least in a specific project some existing made behavior one of activity or meetings group of routine understa adopted? the tool , event or people (e.g. ndable as following develope workshop involved breaking an ways d during ? in the an old importan (convers the project? habit) t thing to ation, project? do? notificati on, stands)? Healthcare 1 2 1 1 1 1 1 UI Design 2 3 2 3 1 2 2 SW Design 2 2 2 2 2 1 3 Development 1 1 1 1 2 3 1

Healthcare UI Design SW Design Development

Figure 56 - Behaviours of Leaders: Did senior clinical leaders promoted leadership of HC members?

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Innovation with the participation of all stakeholders is encouraged. (0=not present; 1 = low, 2 = medium, 3 = high)

3 2

3 1

3 2

3 1

Scientific 0

0 1 2 3 4 5 6 Scientific 0 3 3 3 3 3 0 1 2 1 2 2

Figure 57 Behaviours of HC Teams: was innovation promoted and shared among HC members?

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Formal and informal relationships between professionals with joint activities in different healthcare levels are encouraged. (0=not present; 1 = low, 2 = medium, 3 = high)

0 0,5 1 1,5 2 2,5 3 3,5

3 3 3 3 3

Figure 58 - Behaviours of HC members: were formal and informal relationships encouraged?

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Institutions, community agents, local bodies and the public work together with health institutions in planning community healthcare policies. (0=not present; 1 = low, 2 = medium, 3 = high)

0 0,5 1 1,5 2 2,5 3 3,5

3 2 2 2 2

Figure 59 - Behaviours of HC members: were relationships with Community Stakeholders established?

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The participation of patients and caregivers in associations, working groups, social networks and patient forums is encouraged. (0=not present; 1 = low, 2 = medium, 3 = high)

The fear of failing could be a problem, as the lack of hope, so one should avoid this kind of situations. 1 3 1 2 In this case, stepwise milestones and goals could help.

It may, in that case it is advisable to integrate it as part of a new or a 1 2 2 2 bigger routine.

Were the members triggered to perform this action at least in one of 1 3 3 1 the following ways? 1) Notifications 2) Stands (e.g.: 3) Conversations

Was the behavior adopted? 1 3 2 2

0 1 2 3 4 5 6 7 8 9 Were the The fear of failing members could be a triggered to It may, in that problem, as the perform this case it is lack of hope, so Was the action at least in advisable to one should avoid behavior one of the integrate it as this kind of adopted? following ways? part of a new or a situations. In this 1) Notifications bigger routine. case, stepwise 2) Stands (e.g.: 3) milestones and Conversations goals could help. Healthcare 1 1 1 1 UI Design 3 3 2 3 SW Design 2 3 2 1 Development 2 1 2 2

Healthcare UI Design SW Design Development

Figure 60 - Was participation of patients and caregivers encouraged?

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1.2 Strategic Framework

1.2.2 Measurable Objectives 2 2 (organizational) 1.2.1 Strategic Approach to CC in 2 2 Place (organizational)

0 1 2 3 4 5

Scientific Business

Figure 61 - Value Specifications of the Strategic Framework component of Dimension 1 of the CCM, rated by the Scientific and Business Managers.

1,3 Population Approach

1.3.1.2 Care Model geared to reduce 3 0 2 inequalities (organizational)

1.3.1.1 Care Model geared to improve 3 2 2 health (organizational)

0 1 2 3 4 5 6 7 8

Scientific Business Healthcare

Figure 62 – Value Specifications of the Population Approach component of Dimension 1 of the CCM, rated by the Healthcare, Business and Scientific Managers.

1.4 Information system for evaluation, improvement and innovation

1.4.3.2 Good Practice methods… 3 1 3

1.4.3.1 Collaborative Learning… 2 1 2

1.4.2 Measurements of Quality,… 1 0 2

0 1 2 3 4 5 6 7 8

Scientific Business Healthcare

Figure 63 - Value Specifications of the Information system component of Dimension 1 of the CCM, rated by the Scientific, Business and Healthcare managers.

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1.5 Funding Scheme

1.5.2 Improved Quality of Chronic 3 1 Healthcare (organizational)

1.5.1 Funding Scheme rolled out 0 2 (organizational)

0 0,5 1 1,5 2 2,5 3 3,5 4 4,5

Scientific Business

Figure 64 - Value Specifications of the Funding Scheme component of Dimension 1 of the CCM, rated by the Scientific and Business Managers.

1,6 Social and HC Policies

1.6.1.2 Policies to Promote Integration of 2 2 1 SC and HC (organizational)

1.6.1.1 Policies to Promote Coordination of 2 2 1 SC and HC (organizational)

0 1 2 3 4 5 6

Scientific Business Healthcare

Figure 65 - Value Specifications of the Social and HC Policies component of Dimension 1 of the CCM, rated by the Scientific, Business and Healthcare managers.

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2.1 Community Strategies in Health Plans

2.1.1 Designing Programmes and Community Projects Reflecting Comunity 0 2 3 Needs(service)

0 1 2 3 4 5 6

Scientific Business Healthcare

Figure 66 - Value Specifications of the Community Strategies in Health Plans component of Dimension 2 of the CCM, rated by the Scientific, Business and Healthcare managers.

2.2 Alliances with Community Stakeholders

2.3.1 Meeting the needs of Chronic Patients 2 0 3 (service)

2.2.2 Partnership and Cooperation 2 2 2 (organizational)

2.2.1 Designing Programmes and Community Projects through agreements 3 1 1 (organizational)

0 1 2 3 4 5 6 7

Scientific Business Healthcare

Figure 67 - Value Specifications of the Alliances with Community Stakeholders component of Dimension 2 of the CCM, rated by the Scientific, Business and Healthcare managers.

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Values of Dimensions 3, 4 and 5 Rated by the HC Manager

5.3.1 Face-to-face Interaction among professionals… 1 5.3 Liaison and consultation 5.2.1 Evaluation of Training Programmes… 2 5.2 Continued education and training 5.1.3 Guidelines Protocols and Expert Tools (service). 2 5.1.1 Clinical Practice Guidelne (service). 2 5.1 Protocols and shared guidelines

4.5.2 Patient are involved (service). 3 4.5.1 Patients are well informed (service). 3 4.5 Shared decision-making 4.4.4 Fostering Personal Autonomy and Health (service) 3 4.4 Tools to facilitate self-management 4.3.2 Emotional support is provided (service). 1 4.3.1 Increasing Confidence and Motivation for self-… 3 4.3 Psycho-social development of patients and… 4.2.2 Various types of therapeutic education (service) 3 4.2.1 Providing Therapeutic Education 3 4.2 Structured therapeutic education 4.1.1 Identifying Needs, Attitudes and Self-mgmt Skills… 3 4.1 Patient assessment for self-management

3.7.3 Improve Practice (service) 3 3.7.2 Incentive Schemes for Professionals… 2 3.7.1 Teams are Independent (organizational) 1 3.7 Clinical management of chronic conditions and… 3.6.5 Group Sessions (service) 1 3.6 Innovation in interactions between patients and… 3.5.4 Detect and Address Efficacy, Satety and… 2 3.5.1 Standardised and Personalized Plans of Action… 3 3.5 Active Patient Follow-up. 3.4.5 Alternative Routes for poor control or worsening… 3 3.4.3 Integrated and multidisciplinary care process… 2 3.4.2 Defining and Applying Care Processes (service) 3 3.4.1 Pathways between Primary and Secondary Care… 2 3.4 Integration and Continuity of Care 3.3.4 Shared Goals (service) 1 3.3.3.3 Improvement of Care Models (organizational) 2 3.3.3.2 Improved Implementation (organizational) 1 3.3.3.1 Improved Planning (organizational) 1 3.3 Multidisciplinary teamwork 3.2.4 Emotional Support (service) 2 3.2.3 Management of high-risk chronic patients.… 2

3.2.2 Coordination and Continuity of Care 3 3.2.1 Management of Chronic Patients (service) 3 3.2 Professional Competences Related to Chronic Care. 3.1.4 Keeping patients in their environments (service) 3 3.1.1 HC contact Person (service) 3 0 0,5 1 1,5 2 2,5 3 3,5

Figure 68 - Value Specifications of the HC dimensions (3, 4 and 5) of the CCM rated by the Healthcare Experts.

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System Specifications rated by the Implementation Team

SS 6.3.2: a channel (direct phone line,… 2 2 0 SS 6.3.1: an e-referral or online… 1 3 0 6.3 Reporting of clinical information… SS 6.2.4: information generated in other… 2 3 0 SS 6.2.3: patients can enter clinical… 3 3 3 SS 6.2.2: systems are in place to ensure… 3 3 3 SS 6.2.1: the electronic health record can… 3 3 1 6.2 Integration of patient clinical data SS 6.1.5: the medical record is designed to… 3 3 3 SS 6.1.4: processed data on indicators are… 2 3 3 SS 6.1.2: patient lists can be compiled and… 3 2 2 SS 6.1.1: the risk classification of patients… 3 2 1 6.1 Information for management and…

SS 5.3.2: remote interaction (electronic… 1 3 0 5.3 Liaison and consultation SS 5.1.2: algorithms for alerts and decision… 3 3 2 5.1 Protocols and shared guidelines

SS 4.4.3: self-management tools… 3 3 3 SS 4.4.2: patients have secure electronic … 3 2 3 SS 4.4.1: patients have clear, useful written… 3 3 3 4.4 Tools to facilitate self-management

SS 3.6.4: structured and proactive… 2 3 2 SS 3.6.3: websites, social networks, and… 1 3 2 SS 3.6.2: telemonitoring or… 3 3 3 SS 3.6.1: technology is used to allow… 3 3 3 3.6 Innovation in interactions between… SS 3.5.3: alerts have been set up in the … 3 3 3 SS 3.5.2: a comprehensive care plan for… 3 3 3 3.5 Active Patient Follow-up. SS 3.4.4: alert systems are in place for… 3 3 2 3,4 Integration and Continuity of Care 3.1.2 Patients have a contact number to… 3 3 1 0 2 4 6 8 10

UI Design SW Design Development

Figure 69 - System Specifications rated by the Implementation Team.

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4.6.6 STAGE 5: supporting the evaluation cycle.

a. The evaluation cycle is is described and evaluated through point 8 of Table 26.

Nr. Innovative Methods used Qualitative/ Type Team interventio quantitative Involved n factors 8. Evaluation Artefacts Qualitative OutcomeCoordina cycle – (completion of and tion descriptio formal quantitative n milestones; accomplishment of short/medium/lo ng term outcomes, time and resources utilization)

From the 4th Periodic Management Report (METABO PMR4, 2012): not all the components were ready before the beginning of the trial, their developments in some cases was finalized during the beginning and progressively included in the prototype used by the end-users. This is mainly related with the feedback and alerting messages (which however affected only the 1st week of the first T1DM patient). This was due to the termination of the project for some technical partners, whose work was undertaken by others.

In parallel the approval from the Ethical Committees of the healthcare centres took also much more time than expected.

The project duration was extended of one year, in order to cope with issues and not jeopardize the final evaluation activities.

The pilot activities started on September 2011, when the first investigator meetings took place. The first patients to be included in the study were at the beginning of February 2012, while the last patient terminated the study on September 2012.

A preliminary (as not all patients’ data were ready to be included and analysed) report on the results of the study was issued for the final review of the project, together with the final business plan and a socio-economic analysis reports. All the project milestones were reached (Figure 53).

The project was positively assessed and qualified as “excellent” (maximum rate) by the Expert Panel of the EC.

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Figure 70 - Milestones Reached during the Implementation Phase.

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b. The evaluation phase is analysed through points 9, 10, 11, 12 and 13 of Table 26.

Nr. Innovative Methods used Qualitative/ Type Team Involved interventio quantitative n factors 9. Operation Artefacts Qualitative Process Coordination alization (Training, socio- and and domain economic Develop analysis, mental business Modelling) 10. Uptake Uptake KPIs Quantitative Outcom Coordination e 11. Impact Impact KPIs Quantitative Outcom Coordination e 12. Cost- Cos- Quantitative Outcom Coordination effectiven effectiveness e ess analysis (MAFEIP tool) 13. Disseminat Bibliography Qualitative Process Coordination ion (articles, and and domain patents, grants Develop obtained, mental innovative practice category)

From this point in time, the prospective part of the Case Study starts.

On March 2012, the METABO project was included as part of the commitments that LifeStech research group has presented in the EIP on AHA, in the Action Group A1 – Adherence to Medical Plan. Therefore, the evaluation activities have been continued in the EIP on AHA context and have been focused on measuring impact indicators on T2DM, in a regional context, the Madrid Region.

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Through the procedural steps 9-12 listed in Table 26. The innovation assessment (Figure 45 from section 4.4.3 is reported below) is performed.

Figure 71 - Innovation Assessment Flow.

The operationalization activities are taken from the Business and Organizational Deliverables of the project and reported through the steps indicated in the Scaling Up strategy on AHA (and the information is provided in Italic, in tables).

Before proceeding with the following subsection, excerpts from the Pilot deliverable describing the platform, the main component and the intervention, are provided.

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Description of the Intervention (METABO D4.2, 2012)

The EU co-funded research project “METABO” [reference: EU-FP7-ICT-2007- 1- 216270] was an Information and Communication Technologies (ICT) effort aiming at designing, building and testing an Information Technology (IT) platform to monitor glucose values and lifestyle/ pharmacological factors affecting blood glucose concentrations in patients with diabetes mellitus in real- life situations in order to provide structured information and therapeutic decision support to diabetes care givers.

The IT platform includes a desktop application for the physician and a personal monitoring device (PMD) for the patient. The PMD allows collecting metabolic data, including food and drug intake, physical activity (through the combined use of a pedometer and a wearable “metabolic holter”), discrete glycaemic values (by finger sticks), and continuous sub-cutaneous glucose concentration (by Continuous Glucose Monitoring System, CGMS).

The PMD enables the patient to display simultaneously different metabolic data in an easy-to-understand graphic format in order to improve the interpretation of response to treatment, food and lifestyle.

Different PMD applications were developed for type 1 and type 2 diabetes following a user-centred design, with the identification of two archetypes of patients called “Ana” for type 1 and “George” for type 2.

Two PERSONAS have been defined within METABO: 1. Primary PERSONA: Ana, T1DM young patient insulin treated; most frequent tasks are related to the insertion of medical and biographical data. The functionalities provided by METABO resemble the actions that the patient is used to perform, like the paper diaries or notebooks where patients take note of their measurements and comments. Therefore, “Ana patients” have a fast and easy access to the data insertion functionalities. Patients have access the diary and graphics areas from the home screen, but graphics and diary will not be shown directly on the home screen. Feedback takes place in the form of messages that are related with the correct usage and insertion of the information in the PMD. 2. Secondary PERSONA: George, T2DM aged patient not insulin treated. The focus is not only on data insertion, but on education, and empowerment to adopt a healthier lifestyle. Patients with similar characteristics to George – most elderly T2DM patients – are usually not insulin dependent, suffer a number of comorbidities and have a complex medication regime. The application provides educational content (validated and defined from the clinicians personnel of METABO), aiming to empower patients to change their routines and to adopt a healthier lifestyle. Measurements insertion is still present but the expected frequency insertion is much more reduced (weekly or monthly basis) and it is guided by the application. The interaction is therefore mainly application-driven, that is to say it is expected that often started by the application by prompting messages and reminders about the initiating some activities. These activities can be from reading educational material to doing an exercise (if prescribed) or taking the medication, for example.

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Both Ana and George were provided with two devices: . A Smartphone: data insertion functionalities must be done as soon as the event (food and drug intake, glycaemic measurements) takes place (indoor and outdoor). . A desktop device called Patient Panel: sensor management and data visualization (graphics and charts, educational content) are tasks that are usually carried out when patients are at home, that is why a desktop solution with bigger screens has been implemented for both type of users.

The Control Panel (CP) is a client-based patient-management platform through which the care providers can access in an ordered way all the relevant information of their patients and receive feedback from the METABO Decision Support System. It provides a standard framework of care, based on NHS and ADA guidelines, that structures the patient follow up in four major milestones: diagnosis, education, treatment and complications; providing this way a unique and standardized care pathway. This structure is flexible to permit its adaptation to the needs and requirements of the care providers and the Health Care Centres, bringing efficiency to the daily care processes. The tool allows the care providers to access reliable data, tailor the treatments and define care plans. The CP is based specifically in the analysis of the most common problems that patients encounter as a result of the combination of all the variables that affect their metabolic status and the influence of their environment on them.

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4.6.6.1 Operationalization In this phase, the activities listed in Table 19 of section 4.4.3 are verified, through the technical deliverables reporting on the organisational activities related with the intervention.

. Planning the innovative service & setting up a system for change

Identifying Needs, Securing Political Support, establish multi-stakeholder collaboration, Configuring Business and Reimbursement Model, Securing Financial Support. (METABO D8.5, 2012). Part 1 Along the life of the project, many significant changes have taken place in Europe. Technologically speaking, the access to smart phone devices and the proliferation of health-related applications that run in them has been very vast, forcing the project to adapt to the new trends in SW development and to the new trends in the upcoming market of eHealth.

At the same time Europe has entered a major socio-economic crisis that has started shaking the structures upon which the public social systems have been built for the past 40 years, including the public healthcare systems, which sustainability has been questioned for the first time.

This challenging context, which appears as a threat to the traditional healthcare provision models, represents a great opportunity to the more innovative approaches supported by the use of ICT technology, as they enable the production and provision of completely new services of recognized added value, i.e. remote monitoring and education, etc.; they can ensure equity of access to those services by eliminating the barrier of the “face to face” attention and they have the potential to help curb the costs of the overall healthcare systems in the medium-long term.

METABO has presented a technological solution for the management of diabetic patients that falls under this description. Nevertheless, the greatest challenge that products like this one need to confront is the lack of business models that can support the adoption of these solutions widely by the public healthcare systems. The reasons for this are complex and go beyond the pure market behaviour, but at this moment this subject occupies an eminent space in the European political agenda with the willingness to improve the conditions to introduce new business models for this purpose. In this framework, METABO has developed a long term vision for diabetes management and for the business models associated to it.

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Identifying Needs, Securing Political Support, establish multi-stakeholder collaboration, Configuring Business and Reimbursement Model, Securing Financial Support. (METABO D8.5, 2012). Part 2

Based on a study carried out within the Managed Outcomes project (http://www.managedoutcomes.eu/) in which a deep analysis of the diabetic population was completed for the region of Valencia in Spain, a first segmentation of patients has been completed T2DM considering the developmental stages of the disease, the average length of stay in each of the defined segments and the treatment received in each case.

The impact that an integrated diabetes management program may have in each of the aforementioned stages has been indicated as the potential result of an early and intensive intervention during sustained periods of time in critical moments of the evolution of the disease.

The costs that have been considered to complete the estimation of figures “The Case of Type 2 Diabetes” are based on the results of the studies CODE-2 and T2ARDIS.

Complications and hospitalizations account for the highest costs due to the high number of interventions and hospitalizations incurred and they reflect that patients have entered in stages where their quality of life and productivity worsen significantly.

The following interventions have been designed: . Segment A: Improvement of prevention and screening programs for people at risk together with early intervention programs among the pre- diabetic population (IGT, IFT, IGT+IFT). . Segment B: Improvement and anticipation of diagnose of diabetes together with early treatment and intensive lifestyle intervention. . Segment C: Delay of complications as a result of A and B and of the better monitoring and control during the health maintenance phase (i.e. continuous re-assessment and formation, personalization of treatment, etc.). . Segment D: Reduction of hospitalizations as a result of A, B and C and thanks to specific programs of anticipation and prevention

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Identifying Needs, Securing Political Support, establish multi-stakeholder collaboration, Configuring Business and Reimbursement Model, Securing Financial Support. (METABO D8.5, 2012). Part 3

Most of the efforts of the diabetes management programs are centred in preventing patients from falling into these segments (generally C and D) by focusing the effort in the early stages of the disease, where ensuring a proper care for patients has the potential to delay or avoid the onset of complications.

Figure 72 - Stratification of patients with TYPE 2 DIABETES MELLITUS (from METABO D4.2, 2010). . METABO can make an impact in terms of (Figure 73): 1. Prevention of Diabetes; 2. Earlier treatment and better diagnose; 3. Reduction of complications (main focus of the intervention described in this report); 4. Delay of complications and improved prognostic.

Figure 73 - Estimated Impact of the Intervention (from METABO D4.2, 2012).

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Securing Political Support, reimbursement models, financial support, multi- stakeholder collaboration (METABO D7.4 , 2012) Part 1 An analysis of organizational barriers/facilitators towards introduction of the MEATBO system was carried out.

. Software (SW) engineer is a person, or a team, who knows METABO services and is able to negotiate with Hospital management on the Hospital IT environment. This actor is also responsible for the training of Medical Professionals. . Managers need to approve the use of the system and the changes that come with it. They need to provide the resources necessary for allowing the installation in a specific department, storage of devices and of new generated information. . Security manager, risk manager, someone who can tell what customization it is required to comply with the security rules. METABO complies with EU directives on security of patient data, but still, there can be other specific issues needs to be negotiated with security or risk manager such as machine access info, physical paper storage. Responsible of security need to allow the external connections in and out the hospital security network. . IT staff: department which needs to set up the environment for METABO applications – open ports, generate proxy rules, allow users to computers, assign privileges, arrange 3G data connectivity for patient devices etc. They need to provide technical support in case of HW or SW problems within the professional applications. . Medical professionals interact with METABO by means of the Control Panel, which should run on their computers, so they should be comfortable with the normal usage of a PC system and Windows applications. Medical professionals involved in METABO organisational aspects are the following:  Medical and para-medical professionals – They need to be trained in how to use software applications PMDs and Patient Panel. They need to give support in specific cases such as training, CGMS sensors insertion and education.  Diabetologists and medical specialists – They need to be trained on how to use the Control Panel  Doctors/Personnel responsible for Training in the organization: they need to provide the training

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Securing Political Support, reimbursement models, financial support, multi- stakeholder collaboration (METABO D7.4 , 2012) Part 2

The following organisational and economical barriers were identified.

. Definition of new responsibilities and tasks: adopting the METABO system by a care provider for diabetic patients will first of all modify the current treatment workflow within a hospital, introducing additional responsibilities for several actors while relieving them from some routine treatment steps, like some of the in-clinic routine follow-ups. It should be well defined that the role and responsibility distribution is established for the new treatment workflow within the hospital or clinical centre. A requisite for this is the availability of the suitable billing and documentation system within the hospital to report these activities as treatments to be reimbursed. This requires exhaustive studies that prove the effectiveness, safety and efficiency of the newly proposed treatment strategy. Currently in most of the countries, the outpatient clinics do not take these kinds of services into consideration. . Reimbursement mechanisms. It should be ensured that the required reimbursement mechanisms are put in place. This will depend on the available reimbursement policies in that healthcare institute and more specifically within that country. In the field of cardiology, telemonitoring can substitute in-clinic visits and reimbursement rates are in a more advanced status than in the diabetes field. There is no information on reimbursement rates in diabetes for telemonitoring systems but in the advanced case of cardiology, reimbursement rates vary from state to state, and in some instances are the same as an in-office visit. In the UK, Germany, and Portugal, reimbursement for remote monitoring is similar to that offered for standard follow-up visits. . Requirements for the integration of tele-monitoring into the conventional healthcare system. The necessary directives, regulations, laws and juridical interpretations that direct and manage the lifecycle of remote health monitoring including the reimbursement policy and the integration of telemonitoring into the conventional healthcare system should be available38. . Physician resistance. The use of systems transmitting glycaemic data and feedback to care provider requires a significant amount of time to be handled by the diabetologist, who may be reluctant to analyse all the data sent by the patient to detect potential problems. The importance to provide a reliable and meaningful support to decision, with the objective to catch the attention of the physician in a specific matter, is highlighted. . Legal liability and possible malpractice issues. A legal framework should be put in place by the government that clearly defines the clinical responsibilities and liabilities of medical professionals with respect to the usage of the use of systems transmitting glycaemic data and feedback to care provider, also clear procedure definitions to document alerts and treatments for telemedicine applications should be available.

38 Changes in Healthcare: towards a “patient-centric” approach, Silvio Bonfiglio 201

RESULTS

Securing Political Support, reimbursement models, financial support, multi- stakeholder collaboration (METABO D7.4 , 2012) Part 3 The following needs have been identified:

 Short term pilot studies to evaluate the frequency and reasons of remote systems transmitting glycaemic data and feedback to care provider currently done to define without delay the degree and level of reimbursement.  Cost effectiveness studies of remote systems transmitting glycaemic data and feedback to care provider should be initiated to evaluate the efficiency of various indications for remote monitoring in the national health setting. The results should be used for fine-tuning of the current reimbursement structure.  Physician remuneration for tele-health services should be possible. In some countries, there are incentives for the physicians only for the number physical patient visits, such incentives should also be available for remote monitoring activities. In some regions, the healthcare institutes are funded based on volume of services delivered39, these reimbursement policies should be adjusted to include remote management of systems transmitting glycaemic data and feedback to care provider as a service provided by the healthcare providers. In conclusion: R&D studies like METABO, combined with pilot results that demonstrate economic and clinical benefit, will drive all the stakeholders to establish the legal framework and required reimbursement policies so that a more efficient healthcare management, by the use of systems transmitting glycaemic data and feedback to care provider, can be achieved.

39 Healthcare Unwired, New business models delivering care anywhere, Health Research Institute, Price Waterhouse and Coopers 202

RESULTS

. Organisational process and design choices

Installation and training (METABO D7.4, 2012)

There are several processes which can be done simultaneously, as demanded (or restricted) by the actual hospital policy. In particular, the training on patients PMD applications can be done in parallel to the professional ones. If the trainer has its own PC, the training to medical professionals can also be done in parallel. On the next diagrams the process followed for installing the METABO can be visualized setting aside the project-related development.

Figure 74 - Process description: preparation and installation (METABO D7.4, 2012).

Figure 75 - Process description: platform set-up (METABO D7.4, 2012).

Figure 76 - Process description: initial steps (METABO D7.4, 2012).

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Technical support and troubleshooting, Service re-design and organizational changes (Excerpts from METABO D7.4, 2012) Information of the Madrid Hospital is provided) MADRID – Hospital Clínico San Carlos (HCSC) It was found out that in order to be compliant with the technical security aspects and configuration of the HCSC network the best option was to provide the doctor with a standalone PC (the same tablet-pc that was given to the patients).

An administrator’s account, needed to perform software installations was necessary; the connection to the internet required a HTTPs proxy authentication along with the fact of changing Windows® policies for the several users that were going to use the system made using an external PC the best choice. The standalone PC had to be configured to work within the hospital’s network. In order to achieve it, a security expert technician on the HCSC network system guided technicians from MEDTRONIC and UPM to configure the proxy in the PC. A standalone application called Proxyfier® was used for tunnelling the connections.

During this pre-deployment phase once the applications were installed and configured properly, doctors involved in the pilot were taught on their usage during several meetings.

Doctors had the opportunity to test the progression of the applications as they were not completely bug-free during these pre-deployment months. In parallel to this technical side it was necessary to control the logistics of the devices. All the material received for the execution of the pilot was identified and numbered so it could be easily tracked when the pilot started. A locker with enough space to keep: 4 HTC, 3 Apple iPhone, 5 Asus Tablet PC, 7 Pedometers, 5 Armband, 7 Bayer® Contour Link, 7 Guardian RT, 5 CareLink USB, 4 contour USB cables, 13 Enlite® Sensor Boxes and 30 Contour Glucometer strips was necessary.

As to resume, the actors that were currently involved in the pilot were:

. Two diabetologists who found patients who matched with the protocol inclusion criteria, who used the Control Panel software and provided prescriptions and follow up. . Specialist from HCSC IT division who helped configuring the doctor’s PC within the Hospital’s network policies. . Technical specialist on PMD applications installation, maintenance and configuration. . Technical specialist on glucose monitoring system configuration. . Nurse specialised in the insertion of glucose monitoring sensors for patients, as well as training on the usage of Guardian RT usage. . Nurse who practiced blood analysis to the patients during the required visits of the protocol. The execution of the protocol affected the following organisational hospital units.

. Endocrinology division health care professionals and nurses. . Current treatment workflow within the division introducing additional responsibilities for several actors. . IT division to allow installations and connection requests outside of the hospital network. . Hospital facilities to store the devices a material provided to the patients.

A long term usage of the system would also demand the assessment of billing and reimbursement mechanisms.

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4.6.6.2 Monitoring the Impact Impact of the intervention is assessed through the indicators provided in Table 20, Table 21, Table 22 and Table 23.

Results are provided in the following section, while their interpretation and discussion is reported in STAGE 5 of the Case Study.

Before presenting the results, information on the intervention is taken from the METABO deliverable. Results are reported for both T1DM and T2DM but only for T2DM, and particularized to the Madrid Region, when it comes to the cost- effectiveness analysis, which was performed through the MAFEIP tool of the EIPonAHA.

OBJECTIVES OF THE INTERVENTION (METABO D4.2, 2012) The global aim of the pilot study was to evaluate the usability of the METABO system (PMD + Control Panel) and its acceptability by the patient, and to provide an exploratory analysis of its impact on clinically relevant parameters in type 1 and 2 diabetic patients in comparison with the standard diabetes care (without the use of METABO) for four consecutive weeks.

Based on the exploratory nature of the study, primary efficacy null and alternative hypotheses were not formally established. For this reason, a single primary outcome variable was not identified.

The following assessments have been conducted without a pre-specified hierarchy: . Expected acceptance of the METABO system according to user satisfaction, perceived usefulness, and task adequacy (only medical doctors). . METABO’s goodness of fit into existing healthcare processes by a custom questionnaire for medical doctors (“Organizational Task Adequacy” - Questionnaire) . Patient’s learning success according to an ad-hoc questionnaire. . Change in quality of life by diabetes-oriented QoL questionnaires . Change in blood glucose control by 6-point/day self-blood glucose monitoring . Change in glucose variability by CGMS recording . Patient’s compliance to food suggestions by 6-day food diary recalled by an expert dietician . Patient’s compliance to physical activity goals by pedometer and metabolic holter . Compliance with the use of the system (only in patients randomized to METABO system use) . Safety and tolerability of the system

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Study design Multi-centre, multi-national, open-label, randomized, two-parallel-group exploratory study investigating the acceptance and usability of the METABO system, and comparing the effect of the continuous use of METABO system vs. standard care without the use of METABO for four consecutive weeks on quality of life and clinically relevant parameters associated with glucose control.

All screened patients who fulfilled inclusion and exclusion criteria entered a Baseline Phase of at least 3 days (up to 6 days, based on local monitoring practice). During the Baseline Phase patients recorded metabolic data on food and drug intake (through a portable paper diary), physical activity (through the combined use of a pedometer and a wearable “metabolic holter” device called Armband), discrete glycaemic values (by portable glucometer), and continuous subcutaneous glucose concentration (by Continuous Glucose Monitoring System, CGMS). At the end of the baseline period, patients were assigned to the two treatment groups (METABO or control). Patients assigned to the METABO group were instructed to the use of the METABO PMD and patient’s panel to achieve the recommended goals for four consecutive weeks.

Patients assigned to the Control group were treated and monitored following usual practice. All patients were asked to monitor the complete set of metabolic data during the 3 (6) days of the intervention phase (including the paper diary for food and drug intake).

Figure 77 - Phases of the METABO intervention (from METABO D4.2, 2012).

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Inclusion Criteria Inclusion criteria for this pilot were: . Written informed consent before undergoing any study-related procedure . Both genders, age ≥ 18 years . Type 1 or type 2 diabetes diagnosed following ADA criteria . BMI < 35 kg/m2 . HbA1c < 9% (based on the latest available laboratory exams within the last 6 months) . Absence of significant micro- and macro-vascular complications . Capacity to understand study procedures and the use of a handheld device (PMD) . High level of compliance with investigator’s instructions (as judged by the investigators)

Exclusion Criteria Exclusion criteria for this pilot were: . Age < 18 years . Gestational diabetes or other forms of diabetes not included in the inclusion criteria . Presence of significant micro- and macro-vascular complications, including:  Advanced (proliferative) or laser-treated retinopathy  Renal failure with estimated GFR<60 mL/min or plasma creatinine > 2 mg/dL  Significant autonomic dysfunction  Recent (6 months) cardiovascular events or reperfusion treatments  Heart failure (NYHA class 3 or 4) . Severe, chronic concomitant diseases that are invalidating or life-threatening . Acute or chronic inflammatory or autoimmune diseases . Chronic treatment with systemic corticosteroids . Psychiatric diseases or low-compliance conditions . Pregnant or lactating women, women willing to become pregnant during the study period or carrying childbearing potential without adequate contraceptive measures (based on investigator’s judgment)

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Data Collection At baseline the following data were gathered in all patients: . Clinical data . Demographic data . Diabetes history . Diabetes complications . Past medical history (relevant diseases only) . Physical examination (anthropometrics and vital signs) . Laboratory data The following data were also gathered either during the two data collection periods (from V0 to V1 and from V2 to V3) in all patients or during the overall intervention period in METABO patients:

Table 32: Data collected in the study. METABO METABO All Data group group patients Stratum 1 Stratum 2 Food intake data:

- Through the 6-day diary X X X - Through a dedicated PMD X X application Current medications, including time and dose - Through the 6-day diary X X X - Through a dedicated PMD X X application CSGM data: Medtronic Guardian RT X X1 Glucose fingerstick measurements X1 X1 X1 by glucometer Pedometer data: OMRON Walking X X1 X1 Style Pro Metabolic holter data: Sensewear X X1 Armband Events and notes

- Through the 6-day diary X X X - Through a dedicated PMD X X application 1 Results could be displayed and downloaded by the patient during the intervention period (from V0 to V3)

Data were collected in electronic format through the Control Panel application developed as part of the METABO project, which served as eCRF. Variables not included into the Control Panel database were collected using a dedicated paper CRF. Patients assigned to the METABO group: . were provided with a PMD and a patient’s panel:  Type 1 diabetics (stratum 1) were provided with “Ana” application, which allows collection and display of food and drug intake, physical activity (through the download of pedometer and “metabolic holter” data), discrete glycaemic values (through the download from glucometer), and continuous subcutaneous glucose concentration (through the download from CGMS). Patients were required to

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monitor the complete set of metabolic data for the whole duration of the study. Patients were allowed to download and/or review all metabolic data collected in the four intervention weeks.  Type 2 diabetics (stratum 2) were provided with “George” application, which allows collection and display of food and drug intake, walking activity (through pedometer download), and discrete glycaemic values (through the download from glucometer). Patients were enabled to monitor food and drug intake, walking activity (pedometer) and discrete glycaemic values for the first three weeks of intervention; and were asked to wear the CGMS and the metabolic holter devices only during the last 3-6 days of intervention. Patients were allowed to download and/or review all metabolic data collected in the four intervention weeks, excluding continuous subcutaneous glucose concentration and physical activity data collected though the CGMS and the metabolic holter during the last week. . Patients were followed-up for 4 weeks . All patients wore the CGMS device and the metabolic holter during the last 3-6 days of follow-up to collect metabolic data. In addition, a paper diary for food and drug intake were also filled in. Patients randomized to the CONTROL group: . Continued their regular treatment and were followed-up for 4 weeks . All patients wore the CGMS device and the metabolic holter during the last week of follow-up to collect metabolic data. In addition, a paper diary for food and drug intake were also filled in. Patients were blind to all metabolic data collected. A total of 50 patients were expected to be enrolled in the study. 54 patients have been enrolled in the study. Of these: . 54 started the study . 51 completed the study . 3 withdrew the consent to participate during the study and were therefore discontinued (non-completers) None of the three drop-out patients withdrew from the study due to adverse clinical events related with the use of the system. In all cases, the reason was “consent withdrawal”. The main reason was the heavy burden of activities required by the study, especially in the first and last week. Issues in dealing with the CGMS sensors (in patients not used to insulin pumps and continuous glucose monitoring) were also potential co- causes for discontinuation. The following tables shows how the 51 patients were disposed in the study.

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4.6.6.2.1 Uptake and Impact Indicators This section details the results according to the indicators provided in Table 20.

. KPI1: User Profile:

 Socio-demographic characteristics  Health-related characteristics  Context-related characteristics

Patients were in average of normal weight or slightly overweight, with a long history of disease and a relatively acceptable glucose control (Table 33).

Table 33: Baseline characteristics of the population by gender.

Variable Men Women All (N=36) (N=15) (N=51)

Age 49,1 ± 13 35,1 ± 14 45 ± 13 Body weight at baseline 82.9 ± 17 68.15 ±17 78.6 ± 17.6 Body weight at end of study 81.9 ± 16 68.2 ± 10 78.3 ± 17.4 Type of diabetes * Type 1 19 11 30 Type 2 Insulin Treated 11 2 13 Type 2 Non-Insulin Treated 6 2 8 Duration of diabetes** 17 (13) 10,3 (14) 15,4 (13) HbA1c at baseline 7.5 ± 0.9 7.6 ± 0.9 7.5 ± 0.9 HbA1c at end of study 7.3 ± 1.2 7.2 ± 0.8 7.3 ± 0.8 Footnote: data are expressed as mean ± SD. * data expressed as number of cases; ** data expressed as median (interquartile range)

51 patients started and terminated the study (three dropouts due to personal motivation in starting the study from the patients, not due to adverse event). 25 patients belonged to the control group, while 26 to the intervention arm (Table 34). A prevalence of T1DM subjects and male subjects was present.

Table 34: Total Patient’s disposition Type 1 diabetes Type 2 diabetes Gender METABO control METABO control Males 9 10 10 7 Females 5 6 2 2

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Nearly all participants at V0 had a mobile phone and a PC. 12 Ana and 13 George had a private smartphone, 19 Ana and 7 George did not (Figure 78, Figure 79, Figure 80).

PC ownership (V0); N=51 35 30 25 20 15 no PC 10 5 own PC 0

Figure 78 - PC ownership among subjects.

mobile phone ownership (V0); N=51 35 30 25 20 15 no mobile phone 10 5 own mobile phone 0

Figure 79 - mobile ownership among subjects.

smartphone ownership (V0); N=51 35 30 25 20 15 no smartphone 10 5 own smartphone 0

Figure 80 - Smartphone ownership among subjects.

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T1DM users are more experienced in the use of PCs and smartphones, as their mean usage times demonstrate (Figure 81 and Figure 82).

ICT experience among patients 40 35 30 25 20 Ana 15

hours/week George 10 5 0 PC use time mobile phone smartphone use time use time

Figure 81 - ICT experience among patients: T1DM (blue column), and T2DM (red column). Standard deviation is reported.

Even though, the T2DM group does not appear to have more negative attitudes towards computers than the T1DM group. Computer anxiety is low in both groups.

Computer Anxiety 4,0 3,5 3,0 2,5 2,0 1,5 1,0 1,6 0,5 1,3 0,0 Ana George

Figure 82 - Computer Anxiety for Ana (T1DM) and George (T2DM). Standard deviation is represented too.

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. KPI 2: Usage Behaviours KPIs (METABO group)

 Frequency of use of the system’s features and functions (monthly number of log-ins)  Continued use: extensive and repeated use of the eHealth application until the end of the study period (for example 2 years)  Discontinued use: stopped use of the eHealth application before the end of the study period (search for usage patterns)  Compliance with healthcare advice delivered via eHealth

Next figures show the evolution of the usage of the application and of the compliance to the prescription that the professional sent to the patients, through the application. Figure 83 and Figure 84 show the overall information.

Usage 120%

100%

80%

60% Weeks 1-2 40% Weeks 3-4

20%

0% Blood Drug Physical Food Glucose Intake Activity Intake

Figure 83 - Compliance to the prescribed usage of the System. Standard Deviation is also represented.

Compliance 100% 80% 60% 40% 20% Weeks 1-2 0% Weeks 3-4

Figure 84 - Compliance to the prescriptions. Standard Deviation is also represented.

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Figure 85 and Figure 86 report on usage and adherence per type of disease (Ana and George).

Compliance and Usage T1DM 120,00%

100,00%

80,00%

60,00%

40,00%

20,00%

0,00%

AVG.W1_T1 AVG.W5_T1

Figure 85 - Evolution of the Adherence and System Usage from the first to the last week. Specified for modules and total, for T1DM subjects.

Compliance and Usage T2DM 100,00% 90,00% 80,00% 70,00% 60,00% 50,00% 40,00% 30,00% 20,00% 10,00% 0,00%

AVG.W1_T2 AVG.W5_T2

Figure 86 - Evolution of the Adherence and System Usage from the first to the last week. Specified for modules and total, for T2DM subjects.

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Figure 87. Figure 88. Figure 89 and Figure 90 (“Session” means: the user logs in and then out again) show the “continuity” and “discontinuity” information: almost all patients decreased the time spent in using the application, even though the data packs sent did not decrease in the same way .

PMD Ana - sessions / week 90 80 70

60 Physical Activity 50 Measurements 40 Medication 30 Food 20 10 0 Week 1 Week 2 Week 3 Week 4

Figure 87 - Sessions that T1DM subject has dedicated per each week of the pilot. Standard Deviation is also represented.

PMD Ana - data packs sent / week 80

50 Physical Activity

40 Measurements

30 Medication Food 20

0 Week 1 Week 2 Week 3 Week 4

Figure 88 - Overview of the module usage through data sent, Ana Case. Standard Deviation is also represented.

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PMD George - data packs sent / week 70

50 Physical Activity 40 Measurements 30 Medication 20 Food

0 Week 1 Week 2 Week 3 Week 4

Figure 89 Overview of Module Usage through data sent, George Case. Standard Deviation is also represented.

PMD George - sessions / week 120

100

80 Physical Activity

60 Measurements Medication 40 Food

0 Week 1 Week 2 Week 3 Week 4

Figure 90 Module interactions per week, George Case. Standard Deviation is also represented.

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Figure 91 and Figure 92 show the interaction, on average, that the healthcare professional spent in using the modules and the overall usage time of the Control Panel, respectively.

Figure 91 Control Panel Interactions per module.

Figure 92 Control Panel Interactions per patient.

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. KPI3: User Motivations

 Reasons for (sustained) use: purpose of use and satisfaction (related to features & functions)  Reasons for non-use attrition (e.g., inappropriate information, wrong participants, ease of stopping to use it, lack of push factors, lack of personal contact, lack of positive feedback, lack of observable advantages, intervention has not been paid for, competing interventions, external events, no peer pressure, lack of experience of the user, workload and time required is too much).

The following figures represent how end-users judged the usability factors of the application, in terms of usefulness and user experience.

Figure 93 shows the perceived usefulness for the METABO patients (minimum threshold was 3).

Perceived usefulness 6

0 Ana George

Figure 93 Perceived Usefulness of the METABO solutions. Standard Deviation is also represented.

Figure 94 shows the perceived usefulness for the METABO professionals (minimum threshold was 3).

Perceived usefulness (MDs' view) 6

0 1

Figure 94 Perceived Usefulness from Doctors. Standard Deviation is also represented.

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Figure 95 shows the user experience dimensions for Ana.

User Experience: PMD Ana (HTC) 6 4,7 5 4,3 4,4 4 3,5

0 0 0 0 0

Figure 95 User Experience measured through Attrakdiff: Ana case. Standard Deviation is also represented.

Figure 96 shows the user experience dimensions for George.

User Experience: PMD George (iPhone) 6 5,3 5,2 4,8 5,0 5

0 0 0 0 0

Figure 96 User Experience measured through Attrakdiff: George case. Standard Deviation is also represented.

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Figure 97 shows the user experience dimensions for the Patient Panel (both patients).

User Experience: Patient Panel (Patients' view) 6 4,7 5,0 4,8 4,8 5

0 0 0 0 0

Figure 97 User Experience measured through Attrakdiff: Patient Panel case (patient’s viewpoint). Standard Deviation is also represented.

Figure 98 shows the user experience dimensions for the Medical Doctor (which used the Patient Panel as an ambulatory hub for data download of the medical devices).

User Experience: Patient Panel (MDs' view) 6 5,0 5,0 4,9 5 4,0 4

2 1

0 0 0 0 0

Figure 98 User Experience measured through Attrakdiff: Patient Panel case (Doctors' viewpoint). Standard Deviation is also represented.

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Figure 99 shows the user experience dimensions of the Control Panel.

User Experience: Control Panel 6 5,1 4,8 5,0 5 4,0 4

0 0 0 0 0

Figure 99 User Experience measured through Attrakdiff: Control Panel case. Standard Deviation is also represented.

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4.6.6.2.2 KPIs of the impact on patient healthcare delivery From Table 21, the following KPIs should be measured for assessing the impact on patient healthcare delivery.

KPI1, Increased Access:

. increased availability (healthcare at all times) . increased possibilities (healthcare is provided in many forms) . improved equity (healthcare is available for everyone)

KPI2, Increased efficiency

. reduced utilization of (unnecessary) health care services . time savings via substitution of tasks . improved communication between healthcare professionals . easier handling of healthcare equipment (e.g., guidelines) . reduced healthcare costs

KPI3: Increased safety

. error reduction

KPI4: Increased transparency

. care delivery based on standards as guidelines - protocols for information exchange

KPI5: Improved interaction

. more continuous feedback . between caregivers and patients . among caregivers . among patients . Improved patient-caregiver relationship

KPI6 Improved care delivery

. Increased adherence to guidelines or protocols. . Decision support . Increased satisfaction with care delivery

However, there were no direct measurements that could be directly related to these KPIs. There are no results that can help to draw conclusions for KPI1 (Increased Access), while some statement can be drawn for KPI2 (Increased efficiency). The following results are presented below. In STAGE 6 they are interpreted against the KPIs.

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. Organizational Task Adequacy. Generally, METABO seems to have a rather good fit into the existing routines. However, there are 3 items, among 17, that scored below the middle of the scale, these are:

 the system requires many changes in existing work processes,  it does not allow medical doctors to spend more time on their patients  it does not reflect existing administration processes well.

There are other aspects that differ between countries:

 In Italy there are more concerns about organizational and jurisdictional aspects,  In Spain concerns are about the “non-medical tasks” this system can imply, while they are not scared of legal and ethical aspects.  In the Czech Republic there is belief that the system may improve doctor-patient relationships, but at the same time there is a more general scepticism about the system, even if with less severity of judgment than the others.

. Interaction with the Control Panel: A log-file analysis was carried out to determine which CP modules medical doctors interact with most often. The results shown in Figure 91and Figure 92 show were used also to derive indications for KPI 6 (increased adherence to guidelines and decision support). . Doctor-patient interaction. Table 35 shows the number of messages exchanged between doctors and patients during the pilot.

Table 35: Average number of messages exchanged.

Variable Events Mean ± SD Sum Number of messages exchanged 4,54 ±6,5 26 during week 1 Number of messages exchanged 2,6 ± 3,4 67 during week 2 Number of messages exchanged 1,9 ± 2,7 49 during week 3 Number of messages exchanged 1,1 ± 1,7 29 during week 4

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4.6.6.2.3 KPIs of the impact on patient health & Wellbeing

. KPI1: Improved Quality of Life Indicators

Figure 100, Figure 101, Figure 102, and Figure 104 represent the answers that the intervention and control group gave provided to the quality of life indicators. In all the quality of life questionnaires patients were asked to rate a positive element in a scale from 0 (minimum) to 5 (maximum). Questionnaires were delivered before (V0, Visit 0) and at the end of the study (V3, Visit 3)). In the case of Figure 103 , an ad-hoc questionnaire based on educational quizzes that the application were providing, has been delivered, before and at the end of the study (V3). In the case of Figure 104, a questionnaire asking the importance of an educational topic was asked at V0 and V3.

Quality of Life: ADS 4,0 3,5 3,0 2,5 2,0 CONTROL 1,5 METABO 1,0 0,5 0,0 V0 V3

Figure 100 Quality of Life assessment, before and after the study, between METABO and Control Group. Standard Deviation is also represented.

Quality of Life: Motivation 4,0 3,5 3,0 2,5 2,0 CONTROL 1,5 METABO 1,0 0,5 0,0 V0 V3

Figure 101 Motivation assessment between METABO and CG. Standard Deviation is also represented.

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Quality of Life: Actual 4,0 3,5 3,0 2,5 2,0 CONTROL 1,5 METABO 1,0 0,5 0,0 V3

Figure 102 Actual Quality of Life assessment.

Knowledge gain from V0 to V3 20% 15% 10% 5% 0% CONTROL -5% 1 2 3 4 5 6 7 8 9 METABO -10% -15% -20% -25%

Figure 103 Knowledge gained during the study. Standard Deviation is also represented.

Increase in Knowledge Topic Importance from V0 to V3 2,0

1,0 CONTROL 0,0 1 2 3 4 5 6 7 8 9 METABO -1,0

-2,0

Figure 104 - Perceived importance of the learning topics. Standard Deviation is also represented. (Topic 1: Diabetes Management in general; 2: Hypo/Hyperglycaemia; 3: Complications/comorbidities; 4: BG monitoring/Insulin intakes; 5: Diet; 6: Physical Activity; 7: Pregnancy; 8: Travels; 9: Total).

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. KPI2: Clinical Indicators

Given the reduced number of patients and duration of the study, clinical parameters are not reported, only the most relevant information is given (p<0.05 and 0.05

. Blood Glucose Average before Breakfast improved for the METABO Group, T1DM (, p=0,09) . BG after lunch for all patients improved for the METABO group, before meal (p= 0.007) . Average BG decreased for the METABO group (p= 0,0046) . Average BG for T1 METABO group decreased (p=0,0018) . Glucose Variability (through CGMS) decreased for all METABO group (p=0.006) . T2DM, METABO group made mores steps and METS than Control Group (p=0.03 and p= 0.04) . Overall CHO consumption was reduced in the METABO group (p=0,035) . T2DM, METABO group at Lunch increased for T2DM (p>0.05 and <0.09) . Calories at Dinner decreased for T2DM, METABO group (p>0.05 and <0.09) . Calories decreased for T2DM, METABO group (p>0.05 and <0.09) . Daily Fat decreased for T2DM METABO Group (p>0.05 and <0.09) . Overall variation of Insulin at lunch increased for the METABO group (p=0.030) . Overall variation of Insulin at dinner decreased more in the METABO group (p=0.055) . Overall variation of Insulin at night increased for the METABO group (p=0.039) . Overall variation of Insulin at bedtime decreased for the METABO group (p= 0.048) . T2DM, METABO group decreased insulin intake at breakfast (p=0.055) . Insulin at lunch increased for T1DM METABO (p= 0,032) . Insulin at breakfast increased for T2DM METABO (p= 0.047) . Insulin at bed decreased for T2DM (0.014)

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4.6.6.2.4 Cost-effectiveness analysis This section reports on cost-effectiveness KPIs.

The MAFEIP tool, available as beta version, was used. A report was issued to test the tool and delivered to the EC officers of the MAFEIP project.

The main results are reported below (while they are discussed in STAGE 6 of the Case Study).

Given the early stage of the project results, there are uncertainties related with the generated outcomes. For this reason, the purpose of the early evaluation was to understand:

. How big is the impact of the expected effects? . How sensitive are these outcomes? What are the outcomes of conservative/ optimistic scenarios? . What is the minimal required effectiveness in order to be cost saving or cost- effective? . What are the drivers of the cost-effectiveness? Do we have robust data for those parameters?

The tool was used by populating data for T2DM, focusing on Spanish citizen and when possible data from the Madrid Region, were used (the tool provides data and outputs on a country basis).

The following data were collected to populate model parameters for the interventions:

. Health-related Quality of Life in different health states of the model . Resource use in different health states of the model . Unit costs for resources . Transition probabilities between health states

As the MAFEIP tool estimates the incremental cost and health effects of an intervention over its respective standard care alternative, data were collected for the intervention under assessment and its respective comparator technology (i.e.: current standard of care in T2DM).

The following tasks have been implemented:

1. Identification of all the main characteristics of the diabetes intervention 2. Populating the tool with data for all relevant parameters 3. Reporting and discussion on the results obtained 4. Identification and reporting on any issue encountered with the use of the tool and suggested improvements accordingly.

As mentioned in chapter 3, the current version of the MAFEIP tool allows to populated data for a 3-state Markov Model (future version should allow for 4 states).

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For the intervention under study, the following states have been defined:

. State 1, Baseline Health: T2DM patients without the presence of complications . State 2, Deteriorated Health: T2DM with the onset of one or more than one complications . State 3, Death: Dead T2DM patients.

This decision is motivated by the fact that the exclusion criteria for the METABO study was the presence of complications and, therefore, the target group of the intervention is represented by individuals in State 1.

So, the question is: how long and how much METABO will keep patients stable (State 1) and delay the onset of complications (State 2)?

The following data (Table 36 and Table 37) have been used in terms of transition probabilities.

Table 36 - Current Care Setting

From To Stable, without With Complications Dead Complications Stable, 0.03 Mortality without database+RR Complications from literature With No reversion Mortality Complications Possible database + RR from literature

Table 37 - Intervention Setting.

From To Stable, without With Complications Dead Complications Stable, 0.01 Mortality without database+RR Complications from literature With No reversion Possible Mortality Complications database + RR from literature

These numbers results from the following:

. In Spain, according to the National Statistical Institute40, the yearly increment of +65 population is about 1.63% . According to a study carried out by the Boston Consulting Group (Cronos, 2014), there will be an increase of public health costs in 2011-2020 due to growth of ageing population and bad lifestyle habit. Of these, 2% is due to lifestyle.

40 http://www.ine.es/ 228

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. If METABO has an overall positive effect of increasing adherence up to 70%, and if 80% of high risk complications can be prevented through good habits in terms of lifestyle and follow-up (IDF), the following transition probabilities are given:

 Control Group = 3.62  METABO = 2.22

The following data have been populated for the Relative Risks for Mortality section:

. Relative Risk (RR) of Mortality for Control and Intervention Group at Baseline Case has been taken from a recent meta-analysis on T2DM (Nwaneri et al., 2013) = 1.85 . RR for Control and Intervention Group at Deteriorated State, Hba1C>9% (Nicholas, 2013): = 1.89

The following data have been populated for the Intervention Costs Person Per patient (METABO D8.5, 2012)):

. One-off Intervention Costs per patients= 31€ . Intervention Costs per Person Per Year = 45€

Health State Costs. Information has been gathered for the Madrid Region (Arrieta et al., 2014, Crespo, 2013).

Societal Costs. Information gathered from a report in 5 EU countries (Kanavos, 2012).

. Healthcare Cost in Spain: Spanish Ministry of Health41 . Direct Costs of Diabetes: Elsevier Report on the Spanish Population . T2DM population in Spain (>18 years) = 5.301.314 (FEDE - Federación Española de Diabéticos)

 2.304.919 (43%) undiagnosed  2.996.395 diagnosed

. According to the T2DM segmentation model created in METABO business model, the segment T2B (patient without complications) correspond to the 28%, the number of subjects in this segment corresponds to 838.991. . Direct Health Costs (Spanish Ministry of Health) = 2.095€ per inhabitant (1.530€ public+565€ private) . Total Direct Costs of Diabetes = 5.809M€ . Direct Costs of Complications 2143M€

 Therefore, Direct Cost of Patients without Complications= 3666 M€

41 http://www.msssi.gob.es/estadEstudios/estadisticas/inforRecopilaciones/anaDesarrolloGDR. htm 229

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 Therefore, direct costs for T2DM with Complications= 4.779€ per patient  Therefore, direct costs for T2DM without Complications= 1.223€ per patient

. Indirect Costs are: 17.630 M€

 3.325€ per year, taking into account 5.301.314 of T2DM subjects  5.884€ per year, taking into account only the diagnosed subjects.

Based on the above populated data, the following results have been provided by the MAFEIP tool:

. Incremental costs and effects (age and gender specific, Figure 105 and Figure 106)

Figure 105 - Incremental costs (age and gender specific). Source: MAFEIP tool.

Figure 106 - Incremental effects (age and gender specific). Source: MAFEIP tool.

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. Cost-effectiveness (Figure 107)

Figure 107 - Cost-effectiveness. Source: MAFEIP tool.

. Population flow through model states (Figure 108)

Figure 108 – Population flow through model states. Source: MAFEIP tool.

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. Sensitivity analysis: the MAFEIP tool allows to verify the reliability of the cost- effectiveness outcomes by considering range of values, instead of exact numbers (as shown in Figure 109 and Figure 110). The results are shown in, Figure 111, Figure 112, Figure 113, Figure 114, Figure 115, Figure 116 and Figure 117).

Figure 109 – Sensitivity analysis, the incidence is between 2.12 and 2.32. Source: MAFEIP tool.

Figure 110 - Sensitivity analysis: range of costs, instead of exact numbers were hypothesized. Source: MAFEIP tool.

Figure 111 - Sensitivity analysis for the Incidence Parameter in the intervention case. Source: MAFEIP tool

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Figure 112 – Sensitivity analysis for the Healthcare Costs of stable T2DM in the baseline case. Source: MAFEIP tool

Figure 113 - Sensitivity analysis for the Healthcare Costs of T2DM Complications in the baseline case. Source: MAFEIP tool

Figure 114- Sensitivity analysis for the Healthcare Costs of stable T2DM in the intervention case. Source: MAFEIP tool 233

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Figure 115 – Sensitivity analysis for the Healthcare Costs of T2DM Complications in the intervention case. Source: MAFEIP tool

Figure 116 – “Tornado” diagram, showing the effect on incremental costs that the different parameters have. Source: MAFEIP tool

Figure 117 - Parameter impact on incremental effects (incidence). Source: MAFEIP tool

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4.6.6.3 Dissemination The impact indicators of the dissemination activities are listed below:

. Articles related with the Case Study published by the LifeStech Group (listed in the reference section, under the title: “PUBLICATIONS RELATED WITH THE RESEARCH WORK”, :

 Retrospective part of the case study

o Publications in Journal = 0; o Publication in Conferences= 7;

 Prospective part of the study

o Publications in Journal = 5; o Publication in Conferences = 10;

. Grants, alliance, agreements:

 In 2013, the MOSAIC project has been granted (score 14/15, the author was the research work, coordinated the writing), under the FP7 programme of the EC, in the Virtual Physiological Human area. The project is about developing predictive models for T2DM and develop, out of these models, tools that healthcare professional can use to improve the current detection, risk-stratification and management of T2DM onset and complications. In this proposal, the LifeStech group is the Technical Manager, role played by the author of this research work.  In 2013 the ACT2CARE proposal has been presented (the author was the research work, coordinated the writing) to the Horizon 2020 programme in the mHealth area. The proposal got a score of 13.5/15, based on the concept of patient activation, proactive care team of the CCM and KPIs of the framework were included, among others. However, given the high number of competitive proposals, it was not funded.  In 2014, the author of this research work was selected as a finalist at the IDEA2 Madrid program organized by the M+Vision consortium between the Region of Madrid and the Massachusetts Institute of Technology, with an idea about a device for improving the prevention and the control of the diabetic foot syndrome, thanks to this a multidisciplinary training42 program trasformed a basic idea into a consolidated project proposal that could apply to future funding instruments.  In 2015, the proposal MINIQ has been funded (the project will start in 2016), as an EIT-Health project. Addressing the challenge of

42 News: http://mvisionconsortium.org/ganadores-de-2014-idea%C2%B2-madrid-2/ and http://www.clinicaleven.es/ana-esther-levy-reconocida-por-su-labor-colaboradora-en- madrid-mas-vision-y-el-m-i-t/ accessed November 16, 2015 235

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increasing drug consumption in aging by reducing drug-related illness and hospitalisations among older people, has been funded. In this proposal, written and coordinated by the Aging Research Centre (ARC) of the Karolinska Institutet, the LifeStech will carry out a “Pilot study in year 1 on Diabetes and complication, combining miniQ with the MOSAIC project”, and “will link the project with the Action Group A1 on Prescription and Adherence to medical plans of the EIP-AHA”.  A Collaboration Agreement has been recently signed with the Innovation Unit of the Hospital Clinico San Carlo hospital. This collaboration has, as one of the main objectives, to share information know-how and tools that provide better measurement of the health outcomes that the hospital is currently having to date. The first project that will be executed (under definition, at this moment), will be to use the MOSAIC tools for better risk-stratification of diabetic patients.

. Category of the intervention:

 The intervention has been included in the EIP Repository of Innovative Practices, it has not still peer-reviewed yet. However, according to the type of intervention, could be selected as a Notable practice43.

43 “practices that have been deployed, have shown viability on international, national, regional or local levels and there is some evidence that supports this.” 236

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4.6.7 STAGE 6: Reporting on the results.

a. A report is issued, to refine the framework, describing the way it is delivered to end users, as well as to draw the main conclusions and future works.

The main conclusions of the case study are reported in this section. First, a description of the results derived from each stage is provided and then the overall conclusions are drawn. Finally, a proposal on how deliver the framework to end-users is presented.

4.6.7.1 Supporting The Design Cycle The METABO project aimed at creating ICT-based Personalized Health Systems for patients and healthcare professionals to improve the Management of Diabetes. The project was scored 11.5/15 by the EC expert panel.

Main weaknesses of this project, when evaluated, were:

. Medical Device Interoperability . The expertise and role of some partners were not fitting with the tasks assigned to them. . IPR of the developed solutions could jeopardize the exploitation potential of the project.

Project plan and the innovative development cycles were well defined and designed.

. Stakeholder Analysis:

 Leaders were correctly involved in terms of innovative dimensions and responsibilities.  Healthcare members were correctly covering the secondary care professional figures, while the involvement of primary care professional was not explicit in this project (only one healthcare centre, the Local Healthcare Agency of Modena could cover this expertise, even though the professional figures involved in the project were mainly physicians active in secondary care – i.e. endocrinologists from public hospitals in Modena).  Patient and caregiver groups or associations were not explicitly present in the project.

. The project design cycle was implemented correctly in terms of milestone reached and tasks finalized.

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In terms of HC improvements the METABO project (Figure 48, Figure 49, Figure 50 and Figure 51):

. designed correctly almost all the elements of Patient Activation, with the following exceptions:

 Not defined, from a business case point of view, the elements:

o that improve patient’s sense of RESPONSIBILITY in believing to take an Active Role in the management of the disease, o that allow diabetic patients to make decisions and be more proactive in lifestyle self-management

 Not sufficiently defined contents for informing the patients on their health condition, from the scientific dimension.  Almost (0 in terms of Development dimension, 1 in terms of Healthcare dimension) not defined elements to maintain lifestyle changes against adverse events and during times of stress.

. designed correctly almost all the elements of PROACTIVE and PREPARED CARETEAM, with the following exceptions:

 organizational aspects have not been considered sufficiently, in the Patient DATA REVIEW process (from an Healthcare dimension), nor aspects to foster TEAMWORK (from the HC and Business dimensions) and PATIENT EMPOWERMENT (Business dimension)  the CLINICAL and BEHAVIOURAL intervention that METABO has designed, did not take into account an integration with Clinical Guidelines, nor the systematic involvement of the care team and of the patients in the decision of the care plan  In terms of CONTINUITY of CARE, links with community initiatives were not sufficiently (HC dimension) or not at all (Business dimension) established.

4.6.7.2 Supporting the Implementation Cycle The contractual changes that were defined during the design cycle, to improve the project (e.g. to include a User Centred Design strategy), caused delays that have been propagated to the whole project. The risk identified in the project evaluation, about the lack of expertise from some partners, was confirmed, as some of them had administrative (assessed by the EC) and technical issues (assessed by the coordination team). But this caused not only delay, but a better organization of the activities from the remaining partners.

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As regards the adherence to Behaviours, Values, and Systems Specifications of the METABO project:

. Behaviours of Stakeholders (Figure 54, Figure 55, Figure 56, Figure 57, Figure 58, Figure 59 and Figure 60)

 Leaders: The coordination team defined a clear vision of the project from all the different dimensions ‘perspective, with the exception of the Business viewpoint.  Senior Clinical Leaders did not shared the decision making process well enough among their team members, mainly due to a clear connection between decisions and project events and due to the fact that this may seems as “culturally” unpopular and breaking an existing “hierarchical” routine.  Not all the stakeholders involved in Diabetes have been sufficiently included in the innovation process, from the Business and HC dimensions.  Formal and informal relationships between the different professional figures have been very well established, while sufficiently established the relationships with community agents and bodies  Participation of patients and caregivers was not sufficiently implemented: even though well defined, it was not well designed from the Human Interaction and Healthcare viewpoints, as they were not integrated in existing routines nor planned.

. Values Specifications (Figure 61, Figure 62, Figure 62, Figure 63, Figure 64, Figure 65, Figure 66, Figure 67, Figure 68, Figure 69)

 Dimension 1: the vision of Diabetes Care, the measurement of related objectives and indicators, and a population approach, were confirmed by the Business Manager to be not implemented, differently from the Scientific and HC managers. Funding schemes were not rolled out, according to the Scientific Manager while they were implemented enough, according to the Business Manager. Policies to promote integration and coordination of HC and Social Care were not present, according to the HC manager.  Dimension 2: Programmes linked with community initiatives and based on community needs have not been implemented, according to the Scientific Manager, while they were present, according to the HC and Business Managers. There were elements in support of partnerships and cooperation but they were not officially linked to community stakeholders.  Dimension 3, 4 and 5 (HC system): the project did cover and implement enough almost all the elements of these dimensions, with the exception of:

o Face to face

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o Emotional Support o Team Independence o Group Sessions o Goal Sharing o Improving Planning activities

. System Specifications ( Figure 69), according to the Implementation Team (UI Designer, SW Designer, Developer), almost all the elements of the CCM dimensions (which are present in dimensions 3,4 and 5) have been implemented, with the following exceptions that, have been well defined and designed but not developed:

 An explicit channel for consultations between patient and providers.  Link with information and contents coming from other sectors (e.g.: social networks, blogs, etc.)  EHRs and electronic referral systems were not integrated in the developed solution, even though these components were clearly designed and defined.  Risk classification of patients was not implemented, in this case not even designed.

4.6.7.3 Supporting the Evaluation Cycle The project terminated with 9 months of delay respect to schedule, this mainly due to the previous problems (e.g. partners withdrawal, contractual amendments), but it did not prevented the accomplishment of milestones. The pilot activities were carried out and reported in the METABO final deliverables (one for the results of the pilot, one for the Business Plan and one for the organizational aspects).

. Operationalization. as regard the organizational business and legal aspects, they were properly identified by the project, One of the most distinctive and valued elements developed within the METABO project is the definition of the Business Models that takes into account cost-based and complexity- based stratifications of patients, customer segmentation and are particularized to different cases (B2B, B2C, public and private partnerships). However, the coordination team “had” to establish these alliances with stakeholders out of the consortium. The lack of business alliances established since the beginning of the project has caused a correspondent lack of “healthcare process” outcomes not measured during the pilot activities, like indicators for establishing cost reimbursement or calculation of indicators of the real costs incurred by the healthcare centres (e.g.: nr of patients seen per day, nr and time spent by professionals per patient, times and duration of visits, nr of prescriptions defined, etc.,) before and during the pilot. From an organisational perspective it was also confirmed the importance of integrating such a system with the existing HIS even if for testing purposes only, as the integration in existing routines is a

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fundamental aspect to succeed for innovations that are supposed to add new tasks in the care management procedures.

The presence of the framework helped to re-analyse the project results and to perform further analyses, in order to converge the business, organizational and clinical dimensions in a more holistic view and under the context of the EIPonAHA.

Therefore, the results have been provided using the KPIs that the framework has defined:

. Uptake KPIs:

 User Profiling: socio-demographic and health related characteristics were provided (Table 33 and Table 34) , while context related characteristics were delivered in terms of IT literacy and habits (i.e. PC, mobile and smartphone ownership, computer anxiety and ICT experience; Figure 78, Figure 79, Figure 80, Figure 81 and Figure 82) but not customer-oriented (even though the professional application allow physicians to classify patients according to customer-based scenarios).  Usage Behaviour: good and promising results (statistically beyond the minimum expected thresholds) have been achieved in terms of user compliance to care plans and system usage, for both patients and healthcare providers (Figure 83, Figure 84, Figure 85, Figure 86). T2DM users seemed to maintain a steadier level of motivation of uploading data through the PMD during the trial, even though they also seemed to suffer from a decreased motivation in the final week (Figure 89, Figure 90). Compared to the data they kept introducing during all the four trial weeks, the decrease in usage time indicates a learning effect: users increased their efficiency in using the iPhone app. As regards the Control Panel, it was analysed in which tabs of the care pathway the medical doctors did the most clicks, across all the four test centres Figure 91: these two modules are the “clinical data” tab and the “prescriptions” tab. However, the most interesting question to ask is the amount of time medical doctors needed to sacrifice to the use of the Control Panel (Figure 92). This was calculated per patient treated, as a doctor taking care of 5 patients will obviously need more time for the CP than a doctor taking care of just one patient. The mean time needed to look after one patient in the CP oscillated between 3 and 10 minutes (blue line, Figure 92). In extreme cases, doctors may need up to 20 minutes (as seen in the green line), or only some seconds (as seen in the red line of Figure 92). This value appears to be fair, taking into account that standard monthly visits may take up to one hour. After the definition of the main treatment in the first weeks and after familiarising with the CP, the values are decreasing – even the maximum curve sinks below 5 minutes. To sum it up, the usage

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statistics shows that the patients really used the METABO system, usage and compliance were acceptably high for such a new system. Both, patients and medical doctors, learned to use the system over the weeks of the pilot test and increased their efficiency. The biggest surprise might lie in the fact that the T2DM users, whom we might think of as less capable or willing to use the PMD entered as many measurement values as the T1DM group.  User Motivation: also in this case, user satisfaction, user experience and usability indicators are beyond the minimum expected thresholds, for both patients (Figure 93, Figure 95, Figure 96 and Figure 97) and care providers (Figure 94, Figure 98 and Figure 99). All in all, the patients found the METABO rather useful. The indicated standard deviation of the mean value demonstrates that in this case, the scale middle point of 3 is far from the confidence interval. To sum it up, the users say: METABO was built to do the right thing. From the perspective of the medical doctors, METABO meets the quality criterion. The Control Panel achieved a satisfying evaluation from the medical doctors who used it during the pilot phase. The quality criterion was met.

. Healthcare delivery KPIs:

 Increased Access: these indicators were not measured,  Increased efficiency: the system did not provided integrated care functionalities, so no impact on improving communication between healthcare professionals; nevertheless, there is a positive impact in terms of better utilization of HC services.  Increased transparency: the Control Panel, designed according to the 5 Milestones set out by the American Diabetes Association Guidelines, help to reduce variability in standard of care. However, this element was integrated in the Control Panel from an Interaction Flow view point (i.e..: the professional, for each session has to go through “5 Tabs” each of them specifying the ADA milestones) but not from a traditional Clinical Pathway view point (i.e.: there was not a support to decision based on guidelines embedded in the health record). For this reason, the METABO platform offers functionalities that are rather complementary to computerized clinical guidelines. The project focused more on identifying which were the sequential and logical steps (of the guidelines) to convert them into interaction flows, rather than transforming the contents into hierarchy and rules for automatic reasoning (Fico, 2014a).  Improved Interactions: the system improves patient-provider interactions, the number, type and quality of interactions established are one of the most positive aspects of the trial. However, interaction among caregivers was not explicitly defined by the platform, even though a multi-user interaction with the Control Panel is possible.

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 Improved care delivery: in this case information is taken also from usability testing and user experience results shown to other stakeholders. These results indicate that healthcare professionals consider the platform as a useful tool for diabetes disease management, treatment and patient follow-up, and facilitates substantial reductions of poor practices, hospitalization times, and medical costs in general. It also facilitates patients’ classification according to: specific patient disease history, treatment individualization, patients’ involvement, ongoing support of disease education tools, and management of most of the aspects related to lifestyle changes. All of these are highly desirable characteristics, as recommended by the American Diabetes Association. . Impact on Health and Wellbeing:  Improved clinical values: even though the number of patients and duration of the trial did not allow for a thorough assessment, there are trends that is worth to mention, as shown in section 4.6.6. It seems that BG average values decreased for the METABO group, as well as BG level after lunch and the amount of insulin taken before sleeping and dinner. T2DM stratum made improved the levels of physical activity and diet (less fat and CHO at dinner). The assessment of physical activity by the wearable device leads to similar conclusions: the METABO group showed a more pronounced increase in the average daily energy expenditure due to physical activity compared to the control group. The amount of energy expenditure due to physical activity can be calculated as all energy expenditure recorded by the device when an activity requiring at least 3 METs was performed (and subtracted the basal expenditure). For what concerns food intake, there seems to be an improvement in the nutrients intake, since the intervention group reduced the overall amount of CHO. If this information is interpreted together with the fact that calories consumption at lunch increased, while they decreased, together with fats, at dinner time, seems to be a positive aspect, which matches the slight improvement in glycaemic control observed after dinner. Good results are finally shown for insulin intakes, the intakes at bedtime have decreased for the intervention group, while they increased at lunch (matching the information on BG and Food Intake). Overall, it can be stated that the intervention has generated an improvement of the short-term indicators of clinical benefit. The decrease in BMI and HbA1c levels (not statistically significant) are promising but a longer and bigger trial could confirm this trends.  Improved quality of life and lifestyle: very good results in terms of increased motivation, educational level and quality of life questionnaires, over the threshold. The results obtained about patients’ treatment adherence, educational performance, and patient- provider interaction indicate a significant increase in physical exercise

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and diet follow-up, as well as good comparative results in overall adherence versus focus area with average compliance of over 80%. This means that the system generates a clear beneficial involvement of the patient with the treatment process. Regarding educational tools, results indicate that patients had a high level of interaction with the system’s educational content, and that they improved their level of knowledge about the disease’s management and treatment.

. Cost-effectiveness KPIs:

 the MAFEIP tool was used to perform an analysis about the impact of an intervention focused to stabilize T2DM patients and prevent or delay the onset of complications. The data were collected, when possible, to simulate the intervention in the Spanish healthcare system, in the Madrid region. It seems that the intervention is cost- effective (simulating a prolonged improvement of adherence levels, from 50% to 70%, based on the results of the pilot) and that the data provided are quite reliable, as the sensitivity analysis showed that even in the worst scenario (i.e. direct costs of complications and costs of stable patients), the intervention is still below the Willingness to Pay threshold.  Another benefit resulting from the usage of this tool consisted in a much more clear understanding of the diabetes problem from a health-economy perspective: the current costs provided by existing national and international reports (both public and private institutions) are not well representing the real situation of diabetic patients. Literature is abundant and, at the same time, scarce about this subject, in the sense that, despite the great variety of studies and reports existing on diabetes costs, there is too much discordance and variability of results. This issue was also identified during the METABO project and for this reason, while drafting the business model, the need of creating an ad-hoc cost-stratification of patients was identified.  Another important achievement that has been reached thanks to the MAFEIP tool is that a clear link between the pilot activities, the business plan and the socio-demographic analysis carried out during the METABO project has been established, while this did not happen during the project.  Thanks to this analysis, there was a stronger and consolidated understanding on how to continue the R&D&I activities towards sustainable solutions for diabetes management:

o To identify healthcare centres that have clear, precise and reliable information on costs associated to diabetes, stratified per age and level of complexity

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o In case this not possible, identify healthcare centres that are willing to work together with the innovator in order to provide this information

 Accordingly, develop future versions of the prototypes that allows for implementing stratified interventions, based on the patient segmentation already identified.

4.6.7.4 Final overview of the benefit of the framework on the case study. The framework has provided the following “benefits”:

. Design and Implementation Cycles:

 the concepts and elements of patient activation, proactive and prepared care team, link with community activities, more concrete alliances with healthcare centres sharing the same views in terms of business models and “e-readiness”, have been included in the definition of a research proposal prepared for the Horizon 2020 programme, under the area PHC26 empowering patients with mHealth. The abstract of the proposal is the following:

The main objective of ACT2CARE is to develop an m-health integral service platform for Type 2 Diabetes Mellitus (T2DM). The main value is enabling adult people with T2DM on the self-management of their condition in their living environments, by a continuous process of “patients’ activation” and by enabling “productive interactions” between patients, care givers and the Health Care system. This requires development of a mHealth strategy that aims to: 1) positively influence patient behaviour, increase compliance levels and self-management skills; 2) enable remote management in terms of treatment, monitoring, access to healthcare resources and health risk assessment. A new patient-centric care model is delivered, improving clinical outcomes and avoiding complications and treatment costs. This holistic strategy, will be implemented in a stepwise fashion by: 1) analysing and mitigating risks related to the mHealth adoption (“e-readiness”); 2) promoting, training users about the use of technology; 3) shaping it to the needs and the priorities of the collaborating clinical centres; 4) conceiving it as part of a business model. To achieve this, a community-based platform has been conceived, to reach interoperability with healthcare providers and health ecosystems and adaptability to third parties. The project will assess the impact of this application in a 1 Year longitudinal study in 4 reference centres in Germany, Portugal, Italy and Spain. These centres have clear interests in implementing mHealth’s realizations to optimize and change the way healthcare is delivered.

The proposal got an excellent score (13.5/15, better than METABO, even though it was not funded).  MOSAIC. A proposal focused on professional tools for improving diabetes management was granted (14,5/15). This project is

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developing tools to improve detection and risk-stratification of diabetes onset and complications. The tools developed are including elements that were not present in METABO, as “integrated-care” and “organizational” functionalities, linking primary and secondary care.

. Evaluation Cycle:

 The quantity and quality of publications that the LifeStech group has issued on the subject related to the case study has considerably increased.  The results that the MOSAIC project is delivering, are being linked to the MAFEIP tool, the EIPonAHA and EIT contexts, in order to reduce barriers (EIPonAHA() and accelerate (EIT) uptake of the innovation.

o Pre-post analysis information of costs incurred by the healthcare centres have been included in the project clinical trial (increased access and increased efficiency KPIs). o The MOSAIC tool will be tested with the Hospital Clinico San Carlos (HCSC), in Madrid. This was a partner of the METABO consortium, that has shown interest to use such a tool to understand how improve the current healthcare process for the management of diabetic patients within the Diabetes Unit and, on top of it, to include the new and improved versions of the prototypes developed in METABO. It is also worth to underline that this activity is part of a permanent agreement between the Life Supporting Technologies and the Innovation Unit of the HCSC. This synergy has its foundation on the mutual interest of the two units in making a real impact through innovations by including all the dimensions of research, development, innovation, exploitation from the very beginning. o The MOSAIC intervention is part of new deliverables that LifeStech will deliver through the EIPonAHA, will be assessed through the MAFEIP tool. In this case, the advance over the assessment that was done in METABO is that the majority of the information will be gathered directly from the clinical centres involved in the trial. o The results of the MOSAIC project will be exploited in an “Innovation Accelerator” project, since it has been selected for the innovation by design call of the EIT on Health.

 The METABO intervention has evolved from preliminary, not consolidated assessment of an early prototype to an early stage assessment of innovative eHealth intervention for Diabetes Management: the framework helped to understand how to classify the intervention and what can be used and shared within the scientific, clinical and industrial community, through the EIPonAHA.

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The project has been recently included in the repository of innovative practice and, thanks to the further step (re-analysis of results + cost- effectiveness analysis), could be categorised as a European promising practice of for Active and Healthy Ageing.

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4.6.8 Case study Conclusion: Framework Delivery

Based on the results of the case study and on the validation of the results of this chapter, the framework is now presented in its final form, as a guide that should assist the innovation team working in past, present and future initiatives to improve the management of chronic diseases.

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Section 1

Project Description, Identification of Phases and Framework configuration

. Please describe the intervention in terms of main objectives and milestones. In case of an already funded project, provide a description, how was scored and the main comments received by the judging expert panel. . Please identify the design, implementation and evaluation cycles of the project, in terms of time periods and milestones to be reached for each cycle. . Please determine whether the innovation has been, is being or will be, implemented at a macro, meso or micro level.

. Now, please determined which elements and components of the CCM can be excluded from the evaluation (only those that are not related at all with the innovation).

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. Please describe the stakeholders involved in the project, using the following definitions:

o Leaders o HC team o Care givers

Please state if these actors were clearly part of this project.

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Section 2

Assessment of the Design Cycle

. Please describe the design phase of this project in terms of milestones, outcomes reached and resources utilization.

. Please rate if the project has designed solutions that covers the following HC improvements

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Section 3

Assessment of the Implementation Cycle

. Please describe the implementation phase of this project in terms of milestones, outcomes reached and resources utilization.

. Please rate if the project has implemented solutions that satisfies the following values specifications (if a macro intervention, the CCM dimensions will be evaluated in the order 1-2-3-4-5-6. If not (i.e. meso and micro), the CCM dimensions will be evaluated in the order 3-4-2-1-5-6).

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. Please rate if the project has implemented solutions that satisfies the following values specifications (annex 5 questionnaires).

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Section 4

Assessment of the Evaluation Cycle

. Please describe the evaluation phase of this project in terms of milestones, outcomes reached and resources utilization.

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. Operationalization KPIs

Planning the innovative service & setting up a system for Describe if the change action was implemented Identifying Needs The real needs that the innovation will serve are identified and a strategic implementation plan is consequently defined. Securing Political Committed leadership from central Support and local authorities is present Establish multi- Multi-sectorial stakeholders’ alliances, stakeholder ecosystems, multidisciplinary teams, collaboration new relationships, agreements, bottom-up initiatives, “narratives beyond cost containment” are present. Configuring Shared-risk model, risk and reward Business and share, rental of technology system, Reimbursement self-financing, etc. Model Securing Financial Financial support (e.g.: dedicated Support budget, standardization of procurement, fund-raising organizations) is secured Organisational process and design choices Training and Re- Education of care professionals and skilling the citizens is essential (e.g.: Workforce national/regional/local training strategy, redesign or definition of new roles Technical support 1) ICT solutions are best developed and through active user involvement in troubleshooting the development phase. It is fruitful to have both the ICT provider and the care provider contributing human resources in developing the service platform. 2) Dedicated resources are required to develop and incorporate the technical solutions as part of the daily practice, as well as organise and manage the new service. 3) It is essential to have a team available for continuous development of services and for upgrading the services when new technological possibilities arise. Service re-design Organisational processes, both and organizational clinical and administrative, have to be changes clearly defined and shared among stakeholders. A common intervention plan and agreement for the new services, shared among all the care professionals involved (either from the health care or social care side) is at the foundation.

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. Intervention KPIs

Uptake Description Please describe the KPIs KPIs User  Socio-demographic characteristics Profiling  Health-related characteristics  Context-related characteristics Usage  Frequency of use of the system’s Behaviour features and functions (monthly number of log-ins)  Continued use: extensive and repeated use of the eHealth application until the end of the study period (for example 2 years)  Discontinued use: stopped use of the eHealth application before the end of the study period (search for usage patterns)  Compliance with healthcare advice delivered via eHealth User  Reasons for (sustained) use: Motivations purpose of use and satisfaction (related to features & functions)  Reasons for non-use attrition (e.g., inappropriate information, wrong participants, ease of stopping to use it, lack of push factors, lack of personal contact, lack of positive feedback, lack of observable advantages, intervention has not been paid for, competing interventions, external events, no peer pressure, lack of experience of the user, workload and time required is too much).

Healthcare Description Please describe the KPIs KPIs Increased  increased availability (healthcare at access all times)  increased possibilities (healthcare is provided in many forms)  improved equity (healthcare is available for everyone) Increased  reduced utilization of (unnecessary) efficiency health care services  time savings via substitution of tasks  improved communication between healthcare professionals  easier handling of healthcare equipment (e.g., guidelines)  reduced healthcare costs Increased  error reduction safety Increased  care delivery based on standards as transparency guidelines - protocols for information exchange Improved interaction  more continuous feedback

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 between caregivers and patients  among caregivers  among patients  Improved patient-caregiver relationship Improved  Increased adherence to guidelines care delivery or protocols.  Decision support  Increased satisfaction with care delivery

Health&Wellbeing Description Please describe the KPIs KPIs Improved clinical  Dietary values, HbA1c, blood values pressure, etc.  Decreased mortality  Decreased morbidity Improved quality  social functioning, general or of life mental health, well-being Improved lifestyle  change in attitude and (self-care) increased knowledge, behaviour behavioural intention, and actual behaviour  improved compliance with advice: patient’s adherence to treatment  improved disease control: increased ability to control disease via self-monitoring, education, personal feedback

Uptake KPIs Description Please describe the KPIs Cost-  incremental cost and health- effectiveness related quality of life per age- gender combination in the target population;  average per person incremental effects;  population level impact;  Impact of the intervention on the probability of the patient specified in the input environment to reside in each of the model states.

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Section 5

Reporting

. Now report the main results of this evaluation, in terms of new grants obtained, patients, publication, business improvements, benefits, etc. . According to the report, please indicate the future directions that should be taken in order to improve the results and maximize the success possibilities of your intervention.

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5. CONCLUSIONS

“Learn from yesterday, live for today, hope for tomorrow. The important thing is not to stop questioning.” (Albert Einstein)

In this chapter, the discussion to the research hypotheses and the conclusions to which the research work leads to, are provided. The directions that have been proposed as a continuation of this research are drawn in the conclusive section of this chapter.

CONCLUSIONS

Conclusions

The research work carried out has generated a systematic approach to bring innovations in healthcare systems and improve the way they are currently used to manage chronic diseases.

This approach takes into account all the elements that are needed in order to make it successful, that are:

. Making use of evidence-based healthcare and of methods to transform evidence into actionable knowledge. . Using the eHealth paradigm to translate the actionable knowledge into a holistic and multidisciplinary strategy that describes a healthcare intervention in terms of design, implementation and evaluation cycles, each of them empowered through techniques and methods that allow innovations to be embedded in them. . Recognizing the unique, and still not well understood, characteristics of the creation process that a multidisciplinary team establishes when innovating for improving chronic care. Multidisciplinary Translational Teams working in translating the results of applied health research, need new instruments that are capable of assessing all the developmental steps that occur in the innovation process. . Linking the innovation development cycles to Key Performance Indicators, to relevant healthcare contexts and initiatives (i.e. the EIPonAHA), in order to maximise the impact potential.

Results are promising in terms of the consistency and solidity. The case study helped in defining and understanding how end-users interact with the framework.

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Discussion of the Hypotheses

Hypothesis 1: it is possible to define a translation process to convert a model of chronic care into a structured description of goals, requirements and Key Performance Indicators (KPIs).

By making use of methods that are specific of translating evidence-based healthcare (i.e. the JBI model of evidence-based healthcare) into actions, it was possible to identify the requirements to select and conceptualize an evidence- based model of chronic care. This research work has added the innovation dimension, as an essential component to aid the translation process and make it more powerful. This idea has been taken from the assumption that the eHealth domain can act as catalyst for innovation and as an umbrella under which healthcare interventions can be further elaborated and conceptualized in terms of goals, outcomes and requirements and, through engineering methods, convert them in written, measurable and specified requirements and Key Performance Indicators (KPI). This way, KPIs and specifications can be communicated to the relevant groups of stakeholders involved in the innovation process.

Following the rules defined in the Knowledge Translational Process, the “best available evidence” has been selected. The Chronic Care Model and the CeHReS roadmap are both examples of frameworks built on top of existing evidence. Between the CCM and the CeHReS roadmap, a domain translation process, through Concept Maps and Ontologies, made possible the transition from the healthcare domain to the eHealth domain. Then, the multidisciplinary, iterative, business-oriented nature of the CeHReS roadmap helped to canalize and redirect each element of the CCM, transforming them from a narrative description of outcomes, dimensions, components, and interventions into a measurable set of goals, healthcare improvements, values, attributes, behaviours and system specifications. On top of this, KPIs defined by the Scaling Up Strategy and MAFEIP initiavites of the European Innovation Partnership on Active and Healthy Ageing (which are based on WHO guides, but also on pragmatic elements that policy makers across regional settings have defined), helped to add the elements that are needed to make a thorough assessment of an intervention. The new elements that have been created through this transformation have been categorized and described in the three development cycles of innovation (design, implementation and evaluation). 264

CONCLUSIONS

Existing methods allow to assess Multidisciplinary Translational Team researching in translational healthcare. These methods represent the latest advance in translational health research. Nevertheless, these instruments are focused in translating the results of basic research and not those of applied research. For this reason, the innovative development cycles resulting from the verification of Hypothesis 2, have been included in the MTT methods, and the result is an instrument that is specific for translating applied healthcare evidence-based research.

Hypothesis 4: it is possible to assist the development of innovative solutions for CD management through a reference framework and produce positive effects, measured through KPIs.

Once the framework was created, the need to understand its nature and how it can be used by end-users, brought to the definition of multiple validation activities. Expert’s and non-expert’s opinions were collected, in order to understand the scientific validity and “didactic” clarity of the descriptive components of the framework.

Then, a key case study was selected, in order to answer to a specific Research Question: how is the framework working in which is the best way of supporting end-users in an innovative process?

The case study has simulated the delivery of the framework through a participant-observation data collecting method. The limit of this kind of study resides in the risk of “objectivity”: this risk was addressed by not including the participant as part of the expert panel that judged the main achievements of the project, and by collecting information from official documentation of the project. The advantage of this method is that it helps to gain confidence with the subjects of the study, and to catch insights that are not always available in official reports and documents. For this reason, it was considered as the best instrument to answer to the above research question and thus demonstrate the 4th hypothesis: the framework can assist the development of innovative solutions, This guidance can be retrospective and prospective and can be at micro-meso and macro level, given the nature of the instrument used in the KTPs (i.e.: the ARCHO). The guidance can be provided in the different phases of development, since the framework contains an iterative element, due to the CeHRes Roadmap (from the CEHRES roadmap wiki: “an important aspect of the

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CONCLUSIONS framework is the fact that it is an iterative process, it never stops. After one phase, feedback can be given to an earlier stage of the process and can be adjusted right away”…).

The framework allowed to improve the research activities in different directions: the quality and quantity of the research publications that LifeStech has issued, have increased substantially; 2 project grants to improve the management of diabetes, have been assigned: the first is a grant funding applied research while the second is about accelerating innovations into the market; by using the assessment KPIs of the framework, the proof of concept validation of a prototype developed in a research project was transformed into an early stage assessment of innovative eHealth intervention for Diabetes Management, which has been recently included in the repository of innovative practice of the European Innovation Partnership on Active and Health Ageing initiative.

Main Hypothesis: it is possible to contribute to bridge the gap between healthcare and innovation and, in turn, improve the way chronic care is delivered by healthcare systems.

The verification of the above hypotheses, leads to demonstrate the main hypothesis of this research work.

In order to build “the bridge”, the 2 connecting points (i.e. “Evidence based Healthcare” and “Innovation Cycles”) were identified.

Then, the elements and the procedures needed to build the bridge, were designed, created and used (i.e.: the KTP and its Innovation Blocks).

Once the bridge was built, the best-available “vehicles” that should pass through the bridge have been identified (i.e. the CCM, the ARCHO instruments, the CeHReS roadmap, the MAFEIP, HTAD and Scaling up tools). These vehicles are bringing the innovation “good” from one point to the other, as well as the “instruction” (the procedural component of the framework) on how to “use” and “assess” (i.e.: through the KPIs)the correct functioning of these goods. A representation of the research work is provided in Figure 118.

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Figure 118 - Representation of the Main Hypothesis and Main Objective of the Research Work

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Original Contributions

The main original contributions of this research work are:

1 The definition of a Knowledge Translation Process to convert Evidence-Based- Healthcare into Actionable Knowledge, to improve chronic disease management through innovation.

This new method is a re-elaboration of the JBI model, identifying, for each of the 4 elements, the procedures that allows these elements to be “accelerated” by innovations. More in detail, these elements are:

 Requirements and characteristics that current models of chronic care need to have, based on the policy reports of the last 10 years published by the WHO.  The eHealth paradigm, defined by the European Federation of Medical Informatics as a catalyst for innovation.  The inclusion of KPIs, which allow to measure and monitor healthcare outcomes, and thus verify the improvements that innovations can bring (may these be technological, service delivery and business modelling innovation, as defined by the Harvard Business Review) to existing healthcare settings.

2 A reference framework that describes the Chronic Care Model in terms of design, implementation and evaluation development cycles.

The descriptive component of the framework is a translation of the CCM into a new domain. This translation was iteratively validated and then consolidated with domain experts and students, demonstrating the relevance, the ambition and the importance of the work done.

3 A new procedure to evaluate Multidisciplinary Team working and researching in new solutions for CD management.

The research work has applied methodologies from the Multidisciplinary Translational Team and Health Technology Assessment fields, to derive a new, mixed-method, instrument that assess outcomes, procedures and developmental activities of the team, structured in the design, implementation and evaluation innovation cycles. This procedure include a guidance component to the framework and allows to translate results of applied research into clinical practice.

4 A new instrument that can assist multidisciplinary teams in improving the way they are innovating in CD management.

The case study has demonstrated that the framework can assist a dynamic, heterogeneous and international team of stakeholders innovating for improving the management of diabetes in European healthcare settings. The case study

268

CONCLUSIONS has also demonstrated that the framework contribute to improve research outcomes: new research grants, improved publications, strategic alliances with healthcare providers and canalization of results in the right directions, to reach impact and scale.

This section can be concluded by confirming that the main objective and original contribution of this research work has been achieved:

A systematic approach for designing, implementing and assessing models of chronic care empowered by innovation to assisting every type of healthcare professional in successful delivery of chronic care, has been developed.

269

CONCLUSIONS

Future Work

The main future lines proposed within this research work are the following:

. To continue on the validation activities by selecting two case studies, one for the industrial healthcare sector and the other from the clinical practice sector, this time without the presence of the participant. The objective is to show that the framework can be used by healthcare industries to assess the impact of their interventions and by healthcare providers to understand how they can improve the healthcare delivery in their setting (in this case, a comparison with the ARCHO instrument will be done), . To verify if the framework can be “automatized”, for instance through the inclusion of semantic functions (i.e.: ontologies), in order to be transformed in a tool that supports decision in a semi-automatic and supervised fashion (i.e.: a decision support system for healthcare agents). . To share the framework with the engineering community and contribute to open new horizons in the Clinical engineering and Biomedical engineering domains (e.g. as a new instrument to perform early stage health technology assessment). . To prove that the framework can be proposed as a new instrument to regulate the adoption of innovations in healthcare, conceiving it as a reference for “Innovation Governance”.

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teams: a mixed methods approach. Evaluation & the health professions, 0163278713504433. . World Health Organization. (2013). Innovative care for chronic conditions: building blocks for action. 2002. Available at: http://www.who. int/chp/knowledge/publications/icccreport/en/ - accessed September 21, 2015. . Wuchty, S., Jones, B. F., & Uzzi, B. (2007). The increasing dominance of teams in production of knowledge. Science, 316, 1036–1039. . Yin, R. K. (2013). Case study research: Design and methods. Sage publications. . Zerhouni, E. A. (2006). Clinical research at a crossroads: The NIH roadmap. Journal of Investigative Medicine, 54, 171–173.

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PUBLICATIONS RELATED WITH THE RESEARCH WORK Related with the Framework . Publications in Journal:  Fico, G., Arredondo, M. T., Moreno, E. G., de Retana García, L. O., Serrano-Gil, M., Cornally, N., & Molloy, W. (2014). Analytic Hierarchy Process for Determining the Most Important Factors to Empower Elderly People in Taking an Active Role in Their Health: Study Design. In Ambient Assisted Living and Daily Activities (pp. 390-393). Springer International Publishing. . Publications in Conferences  Fico, G., Gaeta, E., Arredondo, M. T., & Pecchia, L. (2015). Analytic hierarchy process to define the most important factors and related technologies for empowering elderly people in taking an active role in their health. Journal of medical systems, 39(9), 1-7. Related with the Case Study: before the usage of the Framework (2009-2012). . Publications in Journal: None. . Publications in Conferences 1. Guillén, A., Colás, J., Fico, G., & Guillén, S. (2011, August). METABO: A new paradigm towards diabetes disease management. An innovative business model. In Engineering in Medicine and Biology Society, EMBC, 2011 Annual International Conference of the IEEE (pp. 3554-3557). IEEE. 2. Fioravanti, A., Fico, G., Arredondo, M. T., & Leuteritz, J. P. (2011, August). A mobile feedback system for integrated E-health platforms to improve self-care and compliance of diabetes mellitus patients. In Engineering in Medicine and Biology Society, EMBC, 2011 Annual International Conference of the IEEE (pp. 3550-3553). IEEE. 3. Fico, G., Fioravanti, A., Arredondo Waldmeyer, M. T., Leuteritz, J. P., Guillén, A., & Fernandez, D. (2011). A user centered design approach for patient interfaces to a diabetes IT platform. 4. Guillén, A., Colás, J., Fico, G., Ardigó, D., & Fernández, D. (2010, August). Shift from physician-driven care to patient-managed self monitoring and care for chronic diseases related to metabolic disorders. In Engineering in Medicine and Biology Society (EMBC), 2010 Annual International Conference of the IEEE (pp. 6854-6857). IEEE. 5. Fico, G., Fioravanti, A., Arredondo, M. T., & Ardigó, D. (2010, August). A healthy lifestyle coaching-persuasive application for patients with type 2 diabetes. In Engineering in Medicine and Biology Society (EMBC), 2010 Annual International Conference of the IEEE (pp. 2221-2224). IEEE. 6. Fioravanti, A., Fico, G., Arredondo, M. T., Salvi, D., & Villalar, J. L. (2010, August). Integration of heterogeneous biomedical sensors into an ISO/IEEE 11073 compliant application. In Engineering in medicine and

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biology society (EMBC), 2010 Annual international conference of the IEEE (pp. 1049-1052). IEEE. 7. Georga, E., Protopappas, V., Guillen, A., Fico, G., Ardigo, D., Arredondo, M. T., ... & Fotiadis, D. (2009, September). Data mining for blood glucose prediction and knowledge discovery in diabetic patients: The METABO diabetes modeling and management system. In Engineering in Medicine and Biology Society, 2009. EMBC 2009. Annual International Conference of the IEEE (pp. 5633-5636). IEEE. Related with the Case Study: after the usage of the Framework. . Publication in Journal 1. Fabris, C., Facchinetti, A., Fico, G., Sambo, F., Arredondo, M. T., Cobelli, C., & MOSAIC EU Project Consortium. (2015). Parsimonious Description of Glucose Variability in Type 2 Diabetes by Sparse Principal Component Analysis. Journal of diabetes science and technology, 1932296815596173. 2. Zarkogianni, K., Mitsis, K., Litsa, E., Arredondo, M. T., Ficο, G., Fioravanti, A., & Nikita, K. S. (2015). Comparative assessment of glucose prediction models for patients with type 1 diabetes mellitus applying sensors for glucose and physical activity monitoring. Medical & biological engineering & computing, 1-11. 3. Martinez-Millana, A., Fico, G., Fernández-Llatas, C., & Traver, V. (2015). Performance assessment of a closed-loop system for diabetes management. Medical & biological engineering & computing, 1-9. 4. Fioravanti, A., Fico, G., Salvi, D., García-Betances, R. I., & Arredondo, M. T. (2015). Automatic messaging for improving patients engagement in diabetes management: an exploratory study. Medical & biological engineering & computing, 1-10. 5. Fico, G., Fioravanti, A., Arredondo, M., Gorman, J., Diazzi, C., Arcuri, G., ... & Pirini, G. (2014). Integration of Personalized Healthcare Pathways in an ICT platform for Diabetes Management: a small-scale exploratory study. IEEE journal of biomedical and health informatics. . Publication in Conferences. 1. Sambo, F., Di Camillo, B., Franzin, A., Facchinetti, A., Hakaste, L., Kravic, J. Fico G.,.. & Cobelli, C. (2015, August). A Bayesian Network analysis of the probabilistic relations between risk factors in the predisposition to type 2 diabetes. In Engineering in Medicine and Biology Society (EMBC), 2015 37th Annual International Conference of the IEEE (pp. 2119-2122). IEEE. 2. Fico, G., Hernandez, L., Cancela, J., & Arredondo, M. T. (2015). User Centered Design to incorporate predictive models for Type 2 Diabetes screening and management into professional decision support tools: preliminary results. In World Congress on Medical Physics and Biomedical Engineering, June 7-12, 2015, Toronto, Canada (pp. 1389-1392). Springer International Publishing. 3. Sambo, F., Facchinetti, A., Hakaste, L., Kravic, J., Di Camillo, B., Fico, G., ... & Cobelli, C. (2015). A Bayesian Network for Probabilistic Reasoning 282

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and Imputation of Missing Risk Factors in Type 2 Diabetes. In Artificial Intelligence in Medicine (pp. 172-176). Springer International Publishing. 4. Fico, G., Arredondo, M. T., Protopappas, V., Georgia, E., & Fotiadis, D. (2015). Mining data when technology is applied to support patients and professional on the control of chronic diseases: the experience of the METABO platform for diabetes management. In Data Mining in Clinical Medicine (pp. 191-216). Springer New York. 5. Fico, G., Cancela, J., Arredondo, M. T., Dagliati, A., Sacchi, L., Segagni, D., ... & Cobelli, C. (2015, January). User Requirements for Incorporating Diabetes Modeling Techniques in Disease Management Tools. In 6th European Conference of the International Federation for Medical and Biological Engineering (pp. 992-995). Springer International Publishing. 6. Isabel, M. M., Cancela, J., Fico, G., Facchinetti, A., Cobelli, C., & Arredondo, M. T. (2014, June). Can continuous glucose monitoring identify risk factors in type 1 and type 2 diabetes? A literature review. In Biomedical and Health Informatics (BHI), 2014 IEEE-EMBS International Conference on (pp. 248-251). IEEE. 7. Zarkogianni, K., Mitsis, K., Arredondo, M. T., Fico, G., Fioravanti, A., & Nikita, K. S. (2014, June). Neuro-fuzzy based glucose prediction model for patients with Type 1 diabetes mellitus. In Biomedical and Health Informatics (BHI), 2014 IEEE-EMBS International Conference on (pp. 252-255). IEEE. 8. Hernandez, L., Onieva, J., Fico, G., Cancela, J., Dagliati, A., Bucalo, M., ... & Arredondo, M. T. (2014, June). A proposal of architecture to share patients data out of healthcare settings for research purposes. In Biomedical and Health Informatics (BHI), 2014 IEEE-EMBS International Conference on (pp. 789-792). IEEE. 9. Dagliati, A., Sacchi, L., Bucalo, M., Segagni, D., Zarkogianni, K., Martinez Millana, A., ... & Bellazzi, R. (2014, June). A data gathering framework to collect type 2 diabetes patients data. In Biomedical and Health Informatics (BHI), 2014 IEEE-EMBS International Conference on (pp. 244-247). IEEE. 10. Fico, G., Fioravanti, A., Arredondo, M. T., Diazzi, C., Arcuri, G., Conti, C., & Pirini, G. (2014, January). Adaptive Healthcare Pathway for Diabetes Disease Management. In XIII Mediterranean Conference on Medical and Biological Engineering and Computing 2013 (pp. 1468-1472). Springer International Publishin

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ANNEXES

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The following annexes are providing detailed information on some of the instruments (and on the “raw” results, in the case of the questionnaires described in Annex 5) that were used to conduct the research work.

ANNEX 1 – The ARCHO Instrument In this annex, the entire ARCHO instrument is reported (taken from www.iemac.es).

1. ORGANISATION OF THE HEALTH SYSTEM This dimension deals with the transformation of the health system with the aim of improving population health through a shared vision. It is based on adequate funding schemes, information systems that allow for evaluation, improvement and innovation, and the alignment of social and health policies. 1.1 Leadership commitment 1.2 Strategic framework 1.3 Population-based approach 1.4 Information system, evaluation, improvement and innovation 1.5 Funding scheme 1.6 Social and healthcare policies

1.1 Leadership Commitment.

In this context, “leader” is defined as any member of staff with a management role in healthcare organisations and those responsible for teams of staff, depending on the setting in question: regional health service, geographical healthcare area (e.g., district or region), hospital or health centre. A process related to clinical activity in which some health professionals act as leaders with the aim of improving clinical practice and service provision. This is based on the development of competencies to drive strategies, inspire a vision and shared values in professional practice, foster teambuilding, create an organisational culture of innovation and excellence, and develop and prepare professionals for achieving effective management of health problems and excellent care for patients and families

1.1.1 Leaders have developed an explicit vision of chronic care. 1.1.2 Leaders have reallocated resources to drive transformation of the healthcare model with the aim of improving care for chronic patients. 1.1.3 Senior leaders promote clinical leadership among members of multidisciplinary teams*.

1.2 Strategic framework

1.2.1 A strategic approach to chronic care is in place, based on a systemic vision that was developed with the collaboration of stakeholders, bringing together values, quality and responsible use of resources*. 1.2.2 Measurable objectives in the settings relevant to chronic care have been defined and disseminated. 1.2.3 A system for monitoring strategic planning (process and outcomes) in chronic care is in place.

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* 1.2.1. This refers to the concept of the chronic care model as an integrated system overcoming fragmentation between existing care structures by action at various leverage points to achieve better outcomes.

1.3 Population-based approach*

A population-based approach is understood as one which takes the entire population of a certain geographical area into consideration in the design of policies, strategies, and action plans for chronic care. Accordingly, it includes not just patients receiving care but also the healthy population in relation to health promotion activities, in general, and individuals who do not use health services but who could potentially benefit from them. 1.3.2. This refers to the classification of the population into groups that require different interventions or programmes depending on their health status, risk, complexity or needs. To date, the stratification models most widely used classify the population according to their risk of emergency hospitalisation and/or use of other services which imply increased costs in the future. This intervention is addressed from a planning perspective and is complemented by intervention 6.1.1 concerning the individual classification of each patient recorded in their medical record.

1.3.1 The care model is geared to improving health and reducing inequalities and its progress is monitored using indicators.

1.3.2 Population stratification systems providing useful information for clinical and management decisions have been devised and rolled out*

1.4 Information system, evaluation, improvement and innovation

1.4.1 The structure of the information system for evaluation, improvement and innovation has been defined and there is awareness of it

1.4.2 Measurements of quality, health outcomes and efficiency are taken into consideration in the care of chronic conditions.

1.4.3 Methods for collaborative learning, as well as identification and dissemination of good practice are in use.

1.4.4 Innovation with the participation of all stakeholders is encouraged.

1.5 Funding scheme

1.5.1 A risk-adjusted per capita funding scheme has been rolled out*.

1.5.2 Incentives are in place for reaching shared targets in areas of chronic healthcare with the aim of improving the quality of care.

* 1.5.1. Per capita funding is based on the number of people registered in a region, as opposed to schemes based on the funding of hospitals or activity-based programmes (per capita funding is an incentive to keep the population healthy). Per capita payment may be risk-adjusted according to circumstances.

1.6 Social and healthcare policies

1.6.1 Policies to promote coordination and/or integration of social and healthcare have been defined and implemented, especially in cases of frailty and dependence.

2. COMMUNITY HEALTH This dimension refers to cooperation between the healthcare system and community resources, organisations and institutions in the prevention and management of chronic conditions. 2.1 Community strategies in health plans 2.2 Alliances with community stakeholders 2.3 Linking patients to community resources

2.1 Community strategies in health plans

2.1.1 Programmes and community projects are designed reflecting community health needs.

2.1.2 Institutions, community agents, local bodies and the public work together with health institutions in planning community healthcare policies.

2.2 Alliances with community stakeholders

2.2.1 An up-to-date map of community resources that have an impact on health has been developed and is in use.

2.2.2 Partnership and cooperation agreements are in place between healthcare providers and the management of community resources.

2.3 Linking patients to community resources

2.3.1 Channels for accessing community programmes and resources have been set up to meet the needs of chronic patients.

3. HEALTHCARE MODEL This dimension refers to how to advance towards proactive models of care which address the needs of each patient in a comprehensive way and in which the different departments/units and professionals involved carry out their functions in a planned, structured and coordinated manner. 3.1 Patient-centred care 3.2 Professional competencies related to chronic care 3.3 Multidisciplinary teamwork 3.4 Integration and continuity of care 291

3.5 Active patient follow-up 3.6 Innovation in interactions between patients and healthcare professionals 3.7 Clinical management of chronic conditions and incentive schemes

3.1 Patient-centred care*

3.1.1 Chronic patients are able to identify one professional who acts as their healthcare contact person in each care setting*

3.1.2 Patients have a contact number to obtain advice from a healthcare professional on a 24-hour basis (other than emergency services)

3.1.3 A specific action plan has been devised for advanced chronic patients in the last stages of their life, reflecting their values and preferences

3.1.4 An aim of the social care and healthcare provided is for patients to remain in their environment and in the community with the best quality of life possible.

3.1. This refers to planning, organisation and provision of care that takes into account the values, preferences and needs of individual patients and encourages their involvement in the whole process, assisting them in their interaction with the healthcare system and professionals as a means to improve the quality of care they receive. 3.1.1. The healthcare contact person is the professional a given patient identifies as his/her reference in the event of any incidents or questions. The patient knows the name of this professional. It might be their primary care doctor or nurse, a person responsible for patient services or their hospital specialist, depending on the setting. 3.1.2. The channels for consultation must be far-reaching and include the telephone and other communication networks, the possibility of face-to-face consultations and other methods.

3.2 Professional competencies related to chronic care

3.2.1 Professional healthcare competencies required for the management of chronic patients have been established and are developed*.

3.2.2 Certain professionals are given the role of ensuring coordination and continuity of care, particularly in processes of transition between care settings and planning hospital discharge*.

3.2.3 Nurse community case managers are involved in the management of high- risk chronic patients.

3.2.4 Competencies of professionals are developed, in particular for relational skills and skills for motivating patients for change.

* 3.2.1. This refers to the recognition and development of new competencies among health professionals and the development of new profiles with a combination of competencies, to ensure that professionals are better prepared to provide quality care to their chronic patients. Examples of the corresponding new roles may be: health coaching, telephone counselling and the examples discussed in 3.2.2, 3.2.3 and 3.2.4. 3.2.2. These are professionals who participate actively in the planning process at the time of discharge of hospitalised or institutionalised patients, in order to ensure continuity in the care process, to maintain care at home or in other community settings, and to avoid readmission or institutionalisation. Examples would be liaison

nurses and nurse case managers who fulfil this coordination function and ensure continuity of care.

3.3 Multidisciplinary teamwork

3.3.1 Work is carried out in teams in hospitals and other settings*.

3.3.2 Formal and informal relationships between professionals with joint activities in different healthcare levels are encouraged*.

3.3.3 Teamwork between (health, social and community) organisations is facilitated to improve planning, implementation and improvement of care models for chronic patients.

3.3.4 Healthcare teams and other groups involved in patient care in other settings treating the same chronic patients have shared goals.

* 3.3.1 This refers to the rolling out of a team development strategy including the following key elements: identification of team members; definition of their roles and functions; definition of shared goals and corresponding targets, with systematic evaluation of targets reached; and specification of information and communication channels and how often they should be used so that effective cooperation among members is strengthened. The team may range from the basic care unit of the primary care physician and nurse to other larger multidisciplinary and/or inter- area care settings. They may be general or specialised in one or several conditions. 3.3.2 This refers to providing opportunities for professionals to come together and discuss issues of common interest, whether by organising structured activities (seminars, conferences, meetings, etc.) or providing more informal forums for interaction (social networks, knowledge management platforms, social activities, etc.).

3.4 Integration and continuity of care

3.4.1 Pathways between primary and specialist care have been designed and put into place for the most common chronic conditions. These pathways describe the route patients should follow and appropriate healthcare settings based on patient needs.

3.4.2 Care processes take into account the relationship with social care and the community setting.

3.4.3 The integrated and multidisciplinary care process for patients with multiple conditions is defined and applied.

3.4.4 Alert systems are in place for informing and activating the clinical team during referral processes and transitions of care (hospital admission and discharge).

3.4.5 An alternative route, avoiding attendances to the emergency department, has been established for chronic patients during periods of poor control or worsening of their condition: on-line consultations, telephone contact; day

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hospital; and admission, where necessary, managed from the primary care setting.

3.4.6 Medication reconciliation is performed across the continuum of care, and especially during transitions between different settings*.

3.5 Active patient follow-up

3.5.1 Standardised plans of action are in place for each patient profile, including health promotion activities, preventative measures and other interactions in the integrated care process

3.5.2 A comprehensive care plan for each patient, with objectives for prevention, clinical control and symptoms control and self-management, is recorded in his/her medical record.

3.5.3 Alerts have been set up in the information system to make professionals aware that a patient’s condition has become poorly controlled.

3.5.4 Patient medication is systematically reviewed to detect and address any efficacy, safety or adherence problems.

3.6 Innovation in interactions between patients and healthcare professionals

3.6.1 Technology is used to allow remote interaction between patients and professionals*.

3.6.2 Telemonitoring or teleconsultation is commonly used to monitor/follow- up patients.

3.6.3 Websites, social networks, and blogs with health education content are promoted.

3.6.4 Structured and proactive programmes are in place for remote monitoring/follow-up of chronic patients.

3.6.5 Group sessions are held*.

* 3.6.1. This includes telephone calls, as well as e-mail, traditional websites, and Web 2.0 technologies. 3.6.5. The objective is effective improvement in disease management to achieve improvements in health outcomes and a better quality of life. It is based on peer-led interactions, with exchange of knowledge, experience and know-how to produce a change in behaviour allowing effective management of the process.

3.7 Clinical management of chronic conditions and incentive schemes

3.7.1 Healthcare teams have powers to manage their own resources, organisation and operation.

3.7.2 An incentive scheme for professionals is in place that rewards effective management of chronic patients.

3.7.3 Feedback of information is routinely provided to clinicians so that they can improve their practice.

4. SELF MANAGEMENT This dimension refers to the involvement of patients in their own care and the management of their condition. It requires the effective use of support and training strategies to ensure that patients have the necessary motivation, knowledge, skills and resources*. * 4. Active patients who have productive relationships with their medical teams are pivotal in the new models of management of chronic conditions 4.1 Patient assessment for self-management 4.2 Structured therapeutic education 4.3 Psycho-social development of patients and mutual support 4.4 Tools to facilitate self-management 4.5 Shared decision-making

4.1 Patient assessment for self-management

4.1.1 Professionals perform a comprehensive assessment of each case, together with the corresponding patient, to identify the patient’s needs, attitudes and skills for self-management.

4.1.2 Professionals evaluate the environment of each patient with limited autonomy (family and social network, workplace, etc.), together with the corresponding patient, to identify caregivers and their ability to provide the necessary support.

4.2 Structured therapeutic education

4.2.1 Therapeutic education is provided to patients covering all aspects of their chronic condition, through structured programmes

4.2.2 Various types of therapeutic education are provided according to each patient’s needs and preferences: individual appointments, group sessions, telephone calls, emails, specialised websites, on-line courses, educational material, etc.

4.3 Psycho-social development of patients and mutual support

4.3.1 Management skills of patients (for problem-solving, decision-making, and proper use of healthcare and social resources, among others) are developed to increase their confidence and motivation with regard to their self-care ability (expert patient programmes).

4.3.2 Emotional support is provided by patient and caregiver support groups.

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4.3.3 The participation of patients and caregivers in associations, working groups, social networks and patient forums is encouraged.

4.4 Tools to facilitate self-management

4.4.1 Patients have clear, useful written information regarding their personal care plan.

4.4.2 Patients have secure electronic access to “personal health folders”, a part of their medical record that contains comprehensive information related to their condition (diagnosis, treatment, lifestyle recommendations, etc.)

4.4.3 Self-management tools (telephone contact, remote monitoring, patient notes, alerts, devices for measuring biological parameters, pill boxes, etc.) are used as appropriate for each patient.

4.4.4 Programmes of group activities fostering personal autonomy and patient health have been set up.* * 4.4.4. Programmes such as group exercise classes, cooking lessons

4.5 Shared decision-making

4.5.1 Patients receive clear, detailed, relevant information about their health problems and the various care options

4.5.2 Patients are involved in defining problems, in the action plan for negotiating priorities and objectives, and in evaluating their own progress*. * 4.5.2. Once a general assessment of a patient has been made, the professional sets a series of therapeutic objectives with an associated action plan that is a road map stating how the activities and measures required to manage the chronic process are to be carried out. This action plan is agreed with the patient taking into account his/her values and preferences.

5. CLINICAL DECISION SUPPORT This dimension refers to the capacity of the system to improve health outcomes using decision support tools, training of professionals and exchange of knowledge among providers of care to chronic patients. 5.1 Protocols and shared guidelines 5.2 Continued education and training 5.3 Liaison and consultation

5.1 Protocols and shared guidelines

5.1.1 Clinical practice guidelines covering the various care settings and other sources of expert knowledge (decision-making tools, etc.) are used and systematically updated.

5.1.2 Algorithms for alerts and decision making, e.g., diagnosis and point-of-care clinical decision support related to therapeutic interventions, based on clinical practice guidelines, are included in patient medical records.

5.1.3 The design of guidelines, protocols and expert tools covers the most common types of comorbidity.

5.2 Continued education and training

5.2.1 The impact on practice of training programmes on the management of chronic patients and chronic conditions is evaluated.

5.3 Liaison and consultation

5.3.1 Face-to-face interaction (clinical sessions, consultations between professionals, rotations, etc.) is used for the exchange of knowledge and expertise.

5.3.2 Remote interaction (electronic referral of patients, referrals via e-mail, referral via on-line platforms) is used for the exchange of knowledge and expertise.

* 5.3.1. This refers to the transfer of theoretical and empirical knowledge and experience between professionals to assist in the treatment of specific cases or to support training in specific areas. This transfer may occur between professionals with different levels of specialisation, different sectors/levels of care (such as primary care, hospitals, social services, public health) and different types of professionals (medical, nursing, pharmacy and others). It may take place in either one or both directions.

6. INFORMATION SYSTEMS This dimension refers to the use of information to support clinical and population management, distributing relevant information in a structured, proactive and integrated manner between the various information subsystems, to improve care for chronic patients. 6.1 Information for management and clinical practice 6.2 Integration of patient clinical data 6.3 Reporting of clinical information between professionals

6.1 Information for management and clinical practice

6.1.1 The risk classification of patients in terms of their expected care requirements is included in their health record*.

6.1.2 Patient lists can be compiled and activities planned by health problem, risk level or other relevant clinical parameters.

6.1.3 Clinical indicators have been established to assess different dimensions related to chronic conditions: expected prevalence, level of diagnosis, level of

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control, suitability of treatment and adherence, use of hospitalisation and emergency services, complications and mortality.

6.1.4 Processed data on indicators are provided to clinicians and managers on a regular basis to improve practice and management.

6.1.5 The medical record is designed to be user-friendly and ergonomic in order to facilitate clinical monitoring by professionals.

* 6.1.1. This assessment includes the risk of admission, foreseeable complications during treatment, and limited social support, as well as other difficulties.

6.2 Integration of patient clinical data

6.2.1 The electronic health record can be accessed and updated by all care areas

6.2.2 Systems are in place to ensure the unequivocal identification of patients.

6.2.3 Patients can enter clinical information (symptoms, adherence, data from occupational health check-ups or private healthcare, etc.) in their personal health folders within their health record.

6.2.4 Information generated in other sectors (social services, public health) is shared between professionals.

6.3 Reporting of clinical information between professionals

6.3.1 An e-referral or online consultation between professionals from different healthcare areas with electronic exchange of information is in place.

6.3.2 A channel (direct phone line, mobile or other means of contact) is in place for consultations between professionals in real time across the various levels of care.

ANNEX 2 – The CCM-ARCHO Concept Maps In this annex, all the concept maps that were generated from the CCM components, are shown. Actions have been highlighted in red text, Concepts have been highlighted in blue text, while Predicates are in green text.

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Figure 119 - Concept map for the component 1.1 of the Chronic Care Model

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Figure 120 - Concept map for the component 1.2 of the Chronic Care Model

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Figure 121 - Concept map for the component 1.3 of the Chronic Care Model

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Figure 122 - Concept map for the component 1.4 of the Chronic Care Model

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Figure 123 - Concept map for the component 1.5 of the Chronic Care Model

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Figure 124 - Concept map for the component 1.6 of the Chronic Care Model

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Figure 125 - Concept map for the component 2.1 of the Chronic Care Model

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Figure 126 - Concept map for the component 2.2 of the Chronic Care Model

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Figure 127 - Concept map for the component 2.3 of the Chronic Care Model

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Figure 128 - Concept map for the component 3.1 of the Chronic Care Model

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Figure 129 - Concept map for the component 3.2 of the Chronic Care Model

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Figure 130 - Concept map for the component 3.3 of the Chronic Care Model

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Figure 131 - Concept map for the component 3.4 of the Chronic Care Model

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Figure 132 - Concept map for the component 3.5 of the Chronic Care Model

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Figure 133 - Concept map for the component 3.6 of the Chronic Care Model

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Figure 134 - Concept map for the component 3.7 of the Chronic Care Model

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Figure 135 - Concept map for the component 4.1 of the Chronic Care Model

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Figure 136 - Concept map for the component 4.2 of the Chronic Care Model

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Figure 137 - Concept map for the component 4.3 of the Chronic Care Model

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Figure 138 - Concept map for the component 4.4 of the Chronic Care Model

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Figure 139 - Concept map for the component 4.5 of the Chronic Care Model

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Figure 140 - Concept map for the component 5.1 of the Chronic Care Model

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Figure 141 - Concept map for the component 5.2 of the Chronic Care Model

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Figure 142 - Concept map for the component 5.3 of the Chronic Care Model

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Figure 143 - Concept map for the component 6.1 of the Chronic Care Model

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Figure 144 - Concept map for the component 6.2 of the Chronic Care Model

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Figure 145 - Concept map for the component 6.3 of the Chronic Care Model

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ANNEX 3 – Behaviour, values and attributes specifications

In this annex, the behavior specifications of the Chronic Care Model have been elaborated using the Fogg Behavioural Model.

Behaviour Specifications analysed through the Fogg Behavioural Model

Leaders

Description. BS 1.1.1: leaders developed an explicit vision of Chronic Care.

BS 1.1.2: leaders have reallocated resources to drive transformation of the HC model with the aim of improving care for chronic patients.

BS 1.1.3: senior leaders promote clinical leadership among members of multidisciplinary teams.

Triggers Leaders are triggered to perform the above Action in one of the following ways

 Notifications: Emails, etc.

 Stands: Travelling together in meetings, Taking them in events and Waiting out of their office.

 Conversations about the behaviour

Ability Profile Table

Table 38 - Ability Factors Table

Ability Factor Description Answer Time Does the behaviour take a Not if one take profit of cues long time periods: i.e.: if the decision can be linked into project meetings, travelling time, etc.; and if it is done from time to time, once per period and with tools that lower time. The point here is also to avoid interruptions: nights, flights and travels.

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Money Does the behaviour requires No, it is part of their job, already a lot of money paid… Physical Effort Does the behaviour require No significant physical effort Brain Cycles Does the behaviour require Not if all elements for taking significant mental effort decisions (AHP, todolist, RUP) and stimulate creativity (brainstorming, flipcharts, matrixes, stratifications) are provided Social Deviance Is the behaviour strange, out If there is a social media/channel of the norm to transmit the decision and if it is taken on a semi-arranged manner we lower eventual social deviances. But if the decision is unpopular, it may imply a social deviance. Non-Routine Does the behaviour disrupt Not if it is done properly an existing routine (meeting, flights), but as above, it may interrupt an existing routine (it may break an old/bad/undesired habit)

Motivation

Table 39 - Motivation factors

Sensation = Pleasure | Doing something that should improve the way chronic people Pain are treated should be something pleasant to do. Anticipation = Hope | Fear There is no fear but hope in managing. Social Cohesion = Social In case the action is agreed and objectively deemed, the social Acceptance | Social acceptance is high. Shall the actions be unpopular for a part of Rejection all the affected community, the communication of the action and the effort to make it understandable, is an important thing to be done.

Healthcare Professionals, members of a healthcare team

Description. 1.4 Information system for evaluation, improvement and innovation.

BS 1.4.4: innovation with the participation of all stakeholders is encouraged.

2.1 Community strategies in health plans.

BS 2.1.2: institutions, community agents, local bodies and the public work together with health institutions in planning community healthcare policies.

3.3 Multidisciplinary teamwork.

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BS 3.3.2: formal and informal relationships between professionals with joint activities in different healthcare levels are encouraged.

Triggers HC professionals are triggered to perform the above Actions in one of the following ways:

 Notifications: Sent through group emails, Chats, Fora and periodic group meetings (Monday meetings, etc.).

 Stands: Posters, posts it in the offices, newsletters.

 Conversations about the behaviour, briefings, conferences, workshops, peer training and ad-hoc stages.

Ability Profile Table

Table 40 - Ability factors for the members of the HC team

Ability Factor Description Answer Time Does the behaviour take a It may take a lot of time, in this long time case organization and turnovers are important. When not, make behaviours periodic and scheduled is needed. Money Does the behaviour requires No a lot of money Physical Effort Does the behaviour require No significant physical effort Brain Cycles Does the behaviour require In almost the cases, it is part of significant mental effort job activities. Social Deviance Is the behaviour strange, out No of the norm Non-Routine Does the behaviour disrupt In many cases, actions are an existing routine disrupting existing (bad) routines, in this case it is important educate the user about this and make him aware of this situation.

Motivation Table 41 - Motivation factors of the HC team

Sensation = Doing something that should improve the way chronic people are treated Pleasure | Pain should be something pleasant to do. Anticipation = The fear or anxiety of doing something out of the routine, or if not paid or not Hope | Fear recognized by your people could prevail. Defining and share objectives, milestones and goals would minimize anxiety and increase hope. Social Cohesion = There is social pressure to respond promptly and correctly to a required Social Acceptance | action: a feel of social rejection could encourage doing the needed action. Social Rejection

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Informal Care Givers

Description. 4.3 Psycho-social development of patients and mutual support.

BS 4.3.3: the participation of patients and caregivers in associations, working groups, social networks and patient forums is encouraged.

Triggers Informal Caregivers are triggered to perform Action X in one of the following ways

 Notifications: Sent through group emails, Chats, Fora and periodic group meetings (Monday meetings, etc.).

 Stands: Posters, posts it, newsletters.

 Conversations about the behaviour, briefings.

Ability Profile Table Table 42 - ability factors of the patients and informal caregivers

Ability Factor Description Answer Time Does the behaviour take a Not if the IG is knowledgeable long time about the behaviour. Money Does the behaviour requires No a lot of money Physical Effort Does the behaviour require No significant physical effort Brain Cycles Does the behaviour require No significant mental effort Social Deviance Is the behaviour strange, out No of the norm Non-Routine Does the behaviour disrupt It may, in that case it is advisable an existing routine to integrate it as part of a new or a bigger routine.

Motivation Table 43 - Motivation factors for patients and informal caregivers

Sensation = Pleasure | Pain Doing something that should improve the way your beloved’s health should be definitely pleasant. Anticipation = Hope | Fear The fear of failing could be a problem, as the lack of hope, so one should avoid this kind of situations. In this case, stepwise milestones and goals could help. Social Cohesion = Social There is definitely social acceptance in taking actions aiming at Acceptance | Social Rejection improving health status of a cared person.

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ANNEX 4 – Questionnaires used to discuss the ranking of the Hierarchy of Needs

In this annex, the questionnaires used to discuss the results of the ranked healthcare improvements, around the concepts of Patient Activation and Proactive and Prepared Care teams, are provided

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Analytic Hierarchy Process for determining the most important factors to empower elderly people in taking an active role in their health

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First of all, thank you for your time and for taking part of this study aimed at evaluating the key aspects of which are the most important factors to take into account when developing tools for empowering elderly citizens to take an active role in the maintenance of a healthy status.

Introduction

Many methodologies, techniques and technologies exist to empower +65 citizens and patients to be responsible of their health and improve their adherence to plans. Literature provides useful systematic reviews and insights about this topic, but this information is incomplete and could be enhanced by collecting information resulting from in situ experiences that partners of the A1 group have. We are basing our work around the concept of ACTIVATED PATIENT, which is at the basis of the Chronic Care Model44: “An activated patient is a person who has the confidence and skills to engage in a process of shared decision making and take a proactive role in the management of his/her own health”.

Objective

The main objective is to understand, through your help, which are the real needs and challenges in the development and deployment of solutions for activating elderly citizen to take a proactive role in their health care.

44 Wagner E. H., Austin B. T. and Von Korff M., The Milbank Quarterly, “Organizing Care for Patients with Chronic Illness”, Vol. 74, No. 4, pp. 511-544, 1996. 333

The hierarchy

The figure below shows the final hierarchy of needs around the concept of +65 chronic patient “activation” which has been ranked.

Figure 146 Hierarchy of Needs for Citizen/Patient Activation

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Results

The figures below shows the results of this ranking (given as percentage over a total of 100%), we bring the discussion to the 1st two levels, for the sake of ease your answers. Level 1

HAVING AN BELIEFS Being BEING MANTA ACTIVATED CONFIDE PROACTI INING +65 NT AND VE lifestyle PATIENT INFORME change D s

Group result 9% 41% 24% 26%

Level 2

BELIEFS be HC ACTIVE ROLE RESPONSIB professionals determines LE for not main wellness managing actors health

Group result 39% 12% 48%

Being CARE PLAN SELF HEALTH CONFIDENT AND MANAGEME CONDITION INFORMED NT

Group result 41% 32% 27%

BEING DECISIONS LIFESTYLE SELF-CARE PROACTIVE Management

Group result 34% 38% 27%

MANTAINING during times AGAINST ON daily basis lifestyle changes of STRESS things one wants to do

Group result 30% 32% 38%

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Based on the above results: 1. Do you agree with them? How do you interpret them? Please elaborate a little bit on this.

2. Is there something which you do not agree? Why? Please elaborate a little bit on this.

3. According to you, which is the best way of exploiting these results? For instance, think about how this could potentially and positively affect daily practice or the way healthcare services are delivered by healthcare professionals for this Scenario and how this could be communicated to the policy maker or the healthcare professional leader responsible for the related decision. Please elaborate on this.

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That’s all, thank you again for taking part of this study and for your time. Best regards, Giuseppe Fico [email protected] Universidad Politecnica de Madrid Avd. Complutense n30, 28040 Madrid, Spain. www.lst.tfo.upm.es

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Analytic Hierarchy Process for determining the most important factors to empower elderly people in taking an active role in their health

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Introduction

Many methodologies, techniques and technologies exist to empower +65 citizens and patients to be responsible of their health and improve their adherence to plans. Literature provides useful systematic reviews and insights about this topic, but this information is incomplete and could be enhanced by collecting experiences resulting from in situ experiences that partners of the A1 group have. We are basing our work around the concept of PROACTIVE AND PREPARED CARE TEAM, who establish Productive Interactions with an Informed and Activated Patient, which is at the basis of the Chronic Care Model45: “Productive Interactions aim at improving patient outcomes by 1) reviewing data related with patients’ perspectives and critical information about the management of the condition; 2) help patients to set goals and solve problems for improved self- management; 3) apply clinical and behavioural interventions; 4) ensure continuous follow-up”.

Objective

The main objective is to understand, through your help, which are the real needs and challenges in the development and deployment of solutions for establishing a proactive and prepared care team.

45 Wagner E. H., Austin B. T. and Von Korff M., The Milbank Quarterly, “Organizing Care for Patients with Chronic Illness”, Vol. 74, No. 4, pp. 511-544, 1996. 339

The hierarchy

The figure below shows the final hierarchy of needs around the concept of +65 citizen “activation” which has been ranked.

Figure 147 Hierarchy of Needs for Establishing a Proactive and Prepared Care Team

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Results

The figures below shows the results of this ranking (given as percentage over a total of 100%). Level 1

A REVIEW APPLY WORK PROVID PROACTIVE DATA CLINICA ON ING AND WHEN L- IMPROVI CONTI PREPARED MANAGIN BEHAVI NG SELF- NUOUS CARE TEAM G OURAL MANAGE FOLLO CONDITI INTERVE MENT W-UP ON N

Group result 18% 32% 28% 23%

Level 2

REVIEW The The The The DATA ORGANIZ TEAMW DATA PATIEN WHEN ATION ORK ASSESSM T MANAGING ENT EMPO CONDITIO WERME N NT Group result 17% 25% 23% 34%

APPLY Making use of Involving the Working as a CLINICAL- CLINICAL PATIENT TEAM BEHAVIOURAL GUIDELINES INTERVEN Group result 20% 45% 35%

WORK ON GOAL THERAPEUT COACHING IMPROVING SETTING IC ALLIANCE SELF- MANAGEMENT Group result 19% 40% 41%

PROVIDING through COMMUNITY SCHEDULI CONTINUOU REMOTE RESOURCES&INITI NG S FOLLOW- MONITORIN ATIVES UP G Group result 38% 39% 23%

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Based on the above results: 4. Do you agree with them? How do you interpret them? Please elaborate a little bit on this.

5. Is there something which you do not agree? Why? Please elaborate a little bit on this.

6. According to you, which is the best way of exploiting these results? For instance, think about how this could potentially and positively affect daily practice or the way healthcare services are delivered by healthcare professionals for this Scenario and how this could be communicated to the policy maker or the healthcare professional leader responsible for the related decision. Please elaborate on this.

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ANNEX 5 – Questionnaires for the assessment of the design and implementation phases from the Expert Panel of the Case Study

In this annex the following instruments are described:

. the questionnaires sent to the Expert Panel to evaluate the Hiearchies of Healthcare Improvements of the Design Cycle (section “Rating the project design against the HC improvements”), . the questionnaires sent to the Expert Panel to evaluate the Behaviour, Values and Systems Specifications of the Implementation Cycles, are reported (section “Rating the project implementation against the Chronic Care Model components”).

The results of the above questionnaires (section “Raw Results”)

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Rating the project design against the HC improvements.

First of all, thank you for your time and for taking part of this study aimed at evaluating the most important factors to take into account when developing tools for empowering chronic patients to take an active role in the management of their health. These aspects are evaluated in the context of the [Name of the Project] project, in particular of the design phase (the first 18 months).

Introduction

We are basing our work around the concepts of ACTIVATED PATIENT and PROACTIVE AND PREPARED CARE TEAM, which are at the basis of the Chronic Care Model46:  “An activated patient is a person who has the confidence and skills to engage in a process of shared decision making and take a proactive role in the management of his/her own health”.  “Productive Interactions aim at improving patient outcomes by 1) reviewing data related with patients’ perspectives and critical information about the management of the condition; 2) help patients to set goals and solve problems for improved self- management; 3) apply clinical and behavioural interventions; 4) ensure continuous follow-up”.

The hierarchy

Next figures shows two hierarchies of needs that, if covered, will allow to haven an ACTIVATED PATIENT and a PROACTIVE AND PREPARED CARE TEAM. The two hierarchies have been created with the help of healthcare professionals47, in the framework of the European Innovation Partnership on Active and Healthy Ageing48.

46 Wagner E. H., Austin B. T. and Von Korff M., The Milbank Quarterly, “Organizing Care for Patients with Chronic Illness”, Vol. 74, No. 4, pp. 511-544, 1996. 47 Fico, G., Arredondo, M. T., Moreno, E. G., de Retana García, L. O., Serrano-Gil, M., Cornally, N., & Molloy, W. (2014). Analytic Hierarchy Process for Determining the Most Important Factors to Empower Elderly People in Taking an Active Role in Their Health: Study Design. In Ambient Assisted Living and Daily Activities (pp. 390-393). Springer International Publishing. 48 EIP-AHA, official web page: http://ec.europa.eu/research/innovation-union/ index_en.cfm? section=active- healthy-ageing. Accessed 27/06/2014.

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Figure 148 - Hierarchy of Needs for Patient Activation

Figure 149 Hierarchy of Needs for Establishing a Proactive and Prepared Care Team

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Ranking the Hierarchies vs. [Name of the Project]

 0 = not present,  1 = low,  2 = medium,  3 = high. Patient Activation

BELIEFS: The She/he is HC An ACTIVE project has RESPONSIB professionals ROLE worked in creating LE for are not the determines in the patient’s managing main actors wellbeing mind the BELIEF health that:

The patient is CARE PLAN SELF HEALTH being MANAGEME CONDITION CONFIDENT AND NT INFORMED about:

The patient is DECISIONS LIFESTYLE SELF-CARE BEING Management PROACTIVE towards:

The patient, will during times AGAINST ON daily basis MANTAIN lifestyle of STRESS things one changes wants to do

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Now rate the following elements by answering to the following question:

“Did [Name of the Project] designed solutions or defined the conditions to cover the following needs for Proactive and Prepared Care Team?”  0 = not present,  1 = low,  2 = medium,  3 = high.

Proactive and Prepared Care Team.

review DATA The The The DATA The PATIENT WHEN ORGANIZATIO TEAMWORK ASSESSMENT EMPOWERME MANAGING N NT CONDITION

APPLY CLINICAL- Making use of Involving the Working as a TEAM BEHAVIOURAL CLINICAL PATIENT INTERVEN GUIDELINES Group result

WORK ON GOAL SETTING THERAPEUTIC COACHING IMPROVING SELF- ALLIANCE MANAGEMENT

PROVIDING through REMOTE COMMUNITY SCHEDULING CONTINUOUS MONITORING RESOURCES&INITIATI FOLLOW-UP VES

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Rating the project implementation against the Chronic Care Model components.

The implementation phase is analysed through the multidisciplinary requirement table, to observe if, and how, behaviours, values, attributes and system specifications are defined and verified.

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Behaviour of Leaders. Please rate the following table: 0 = not present, 1 = low, 2 = medium, 3 = high.

Description of behaviour Was the Was the leader triggered to perform Was the Was the Was the Was the decision Was the decision behaviour this action at least in one of the decision decision decision interrupting an properly adopted following ways? 1) Notifications (e.g.: linked to stimulated unpopular existing routine (e.g. communicated, emails, calls, etc.). 2) Stands (e.g.: project through a for some breaking an old habit) made travelling together during meetings, meetings, specific group of understandable pursuing them out of events, waiting event or activity or people as an important them out of their office…); 3) workshop? tool involved in thing to do? Conversations about the behaviour developed the project? during the project? 1: The coordination team developed an explicit vision of Chronic Care. 2: The coordination team: allocated resources to drive transformation of Diabetes Care with the aim of improving care for diabetic patients. 3: Senior leaders of the Clinical partners promoted clinical leadership among members of multidisciplinary teams.

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Behaviour of Healthcare professionals, members of a healthcare team. Please rate the following table: 0 = not present, 1 = low, 2 = medium, 3 = high.

Description of behaviour Was the Were the members triggered to perform this Were organization Were Were Was the behaviou action at least in one of the following ways? 1) and turnovers members objectives, behaviour r Notifications (e.g.: group emails, fora, periodic implemented or educated milestones promoted adopted group meetings, etc.). 2) Stands (e.g.: Posters, periodic and about this or goals enough? ? posts it in the offices, newsletters, etc.); 3) scheduled meeting behaviour and defined and Conversations about the behaviour, briefings, organized in order to made aware of shared conferences, workshops, peer training and ad- achieve the this situation? around this hoc stages behaviour? behaviour?

Innovation with the participation of all stakeholders is encouraged. Institutions, community agents, local bodies and the public work together with health institutions in planning community healthcare policies. Formal and informal relationships between professionals with joint activities in different healthcare levels are encouraged.

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Behaviours of patients, their relatives and informal care givers. Please rate the following table: 0 = not present, 1 = low, 2 = medium, 3 = high.

Description of behaviour Was the Were the members triggered to perform this It may, in that case it The fear of failing could be a behaviour action at least in one of the following ways? 1) is advisable to problem, as the lack of hope, so adopted? Notifications (e.g.: group emails, fora, periodic integrate it as part of one should avoid this kind of group meetings, etc.). 2) Stands (e.g.: Posters, a new or a bigger situations. In this case, stepwise posts, newsletters, etc.); 3) Conversations about routine. milestones and goals could help. the behaviour, briefings, peer training)

The participation of patients and caregivers in associations, working groups, social networks and patient forums is encouraged.

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Dimensions 1: Organization of Health Care.

Please rate the following table: 0 = not present, 1 = low, 2 = medium, 3 = high.

1.2 Strategic Framework Value Specification Is the project defining this value? Is the project (Document source, reference) verifying this value? (Document source, reference) Value Attribute(s) 1.2.1 Strategic Systematic Vision Approach to CC in Developed with Place Stakeholders (organizational) Bringing values, quality and responsible use of resources

Value Attribute(s) 1.2.2 Measurable Definition and Objectives Dissemination in (organizational) the relevant settings System Specification 1.2.3 System for monitoring strategic planning (process and outcomes) in chronic care is in place. Organizational and Functional.

1.3 Population Based Approach. Value Specification Is the project defining this value? Is the project (Document source, reference) verifying this value? (Document source, reference) Value(s) Attribute(s) 1.3.1.1 Care Model Measure geared to improve Progress by health Indicators (organizational) 1.3.1.2 Care Model geared to reduce inequalities (organizational)

System Specification Is the project defining this System Is the project Specification? verifying this System Specification? 1.3.2: population stratification systems providing useful information for clinical and management decisions have been devised and rolled out (Organizational and Usability).

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1.4 Information system for evaluation, improvement and innovation. Value Specification Is the project defining this value? Is the project (Document source, reference) verifying this value? (Document source, reference) Value(s) Attribute(s) 1.4.2 Taken into Measurements of consideration Quality, Health Outcomes and Efficiency (organizational) 1.4.3.1 In use Collaborative Learning methods (service) 1.4.3.2 Good Practice methods (service) System Specification Is the project defining this System Is the project Specification? verifying this System Specification? SS 1.4.1: the structure of the information system for evaluation, improvement and innovation has been defined and there is awareness of it (Organizational and Usability).

1.5 Funding Scheme. Value Specification Is the project defining this value? Is the project (Document source, reference) verifying this value? (Document source, reference) Value(s) Attribute(s) 1.5.1 Funding Risk-Adjusted Scheme rolled out Per Capita (organizational) 1.5.2 Improved Incentives for Quality of Chronic Shared targets Healthcare (organizational)

1.6 Social and HC Policies. Value Specification Is the project defining this value? Is the project (Document source, reference) verifying this value? (Document source, reference) Value(s) Attribute(s) 1.6.1.1 Policies to  Defined and Promote Implemented Coordination of  Especially for SC and HC

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(organizational) Frailty and 1.6.1.2 Policies to Dependence Promote Integration of SC and HC (organizational)

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Dimension 2: Community Resources and Policies

2.1 Community strategies in health plans. Value Specification Is the project defining this value? Is the project (Document source, reference) verifying this value? (Document source, reference) Value(s) Attribute(s) 2.1.1 Designing Risk-Adjusted Programmes and Per Capita Community Projects (service)

2.2 Alliances with community stakeholders. Value Specification Is the project defining this value? Is the project (Document source, reference) verifying this value? (Document source, reference) Value(s) Attribute(s) 2.2.1 Designing Reflecting Programmes and Community Community Health Needs Projects (organizational) 2.2.2 Partnership Through and Cooperation Agreements (organizational) between HC providers and CR managers

2.3 Linking patients to community resources... Value Specification Is the project defining this value? Is the project (Document source, reference) verifying this value? (Document source, reference) Value(s) Attribute(s) 2.3.1 Meeting the Setting Up needs of Chronic Channels for Patients (service) Accessing Community Programmes and Resources

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Dimension 3: Self-Management Support

3.1 Patient-centred care Value Specification Is the project defining this value? Is the project (Document source, reference) verifying this value? (Document source, reference) Value(s) Attribute(s) 3.1.1 HC contact Patients Are Able Person (service) to identify it

In each Care Setting

Value Attribute(s) 3.1.4 Keeping Supported by HC patients in their and SC environments (service) With the best quality of life possible

System Specification Is the project defining this System Is the project Specification? verifying this System Specification? 3.1.2 Patients have a contact number to obtain a device from a healthcare professional on a 24-hour basis (other than emergency services). (functional)

3.2 Professional Competences Related to Chronic Care. Value Specification Is the project defining this value? Is the project (Document source, reference) verifying this value? (Document source, reference) Value(s) Attribute(s) 3.2.1 Management Through of Chronic Development of Patients (service) Specific Professional Competencies

Value Attribute(s) 3.2.2 Coordination Giving this role to and Continuity of certain Care Professionals Coordination and Continuity of Care Particularly in the (service) transition between care settings and hospital 356

discharge

3.2.3 Management Involving Nurse of high-risk Community Case chronic patients. Managers (service) 3.2.4 Emotional Relational Skills Support (service) Behavioural Change Skills

3.3 Multidisciplinary teamwork Value Specification Is the project defining this value? Is the project (Document source, reference) verifying this value? (Document source, reference) Value(s) Attribute(s) 3.3.1 Teamwork Carried out in (organizational) hospital and other settings

Value Attribute(s) 3.3.3.1 Improved Teamwork Planning between health, (organizational) social and community With the best quality of life possible

3.3.3.2 Improved Implementation (organizational) 3.3.3.3 Improvement of Care Models (organizational) 3.3.4 Shared Goals Among (service) professionals treating the same patients

3.4 Integration and Continuity of Care Value Specification Is the project defining this value? Is the project (Document source, reference) verifying this value? (Document source, reference) Value(s) Attribute(s)

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3.4.1 Pathways For the most between Primary common conditions and Secondary Describing route and Care (service) appropriate care settings Based on Patient Needs 3.4.2 Defining and Taking into account Applying Care social care and Processes (service) community settings 3.4.3 Integrated For Patients with and Multiple Conditions multidisciplinary are integrated and care process Multidisciplinary (service)

3.4.5 Alternative Avoiding emergency Routes for poor attendances control or Online Consultations worsening (service) and Phone contact

Day Hospital Managed from Primary Care Settings, where necessary. System Specification Is the project defining this System Is the project Specification? verifying this System Specification? SS 3.4.4: alert systems are in place for informing and activating the clinical team during referral processes and transitions of care (hospital admission and discharge). (service)

3.5 Active Patient Follow-up. Value Specification Is the project defining this value? Is the project (Document source, reference) verifying this value? (Document source, reference) Value(s) Attribute(s) 3.5.1 Standardised For each Patient and Personalized Profile Plans of Action (service)

Health Promotion Activities

Preventative Measures

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Interactions in the Integrated Care Process

3.5.4 Detect and Through Systematic Address Efficacy, Review of Patient Safety and Medication Adherence (service)

System Specification Is the project defining this System Is the project Specification? verifying this System Specification? SS 3.5.2: a comprehensive care plan for each patient, with objectives for prevention, clinical control and symptoms control and self-management, is recorded in his/her medical record. (functional) SS 3.5.3: alerts have been set up in the information system to make professionals aware that a patient’s condition has become poorly controlled. (functional)

3.6 Innovation in interactions between patients and healthcare professionals. Value Specification Is the project defining this Is the project verifying this value? value? (Document source, reference) (Document source, reference) Value(s) Attribute(s) 3.6.5 Group are Held Sessions (service) System Specification Is the project defining this Is the project verifying this System Specification? System Specification? SS 3.6.1: technology is used to allow remote interaction between patients and professionals (usability). SS 3.6.2: telemonitoring or teleconsultation is commonly used to monitor/follow-up patients (functional). SS 3.6.3: websites, social networks, 359

and blogs with health education content are promoted (service and usability). SS 3.6.4: structured and proactive programmes are in place for remote monitoring/follow-up of chronic patients (functional).

3.7 Clinical management of chronic conditions and incentive schemes. Value Specification Is the project defining this Is the project verifying this value? value? (Document source, reference) (Document source, reference) Value(s) Attribute(s) 3.7.1 Teams are In terms of Independent Resources, (organizational) Organization and Operation 3.7.2 Incentive Rewarding Schemes for effective Professionals management of (organizational) patients 3.7.3 Improve Through Practice (service) feedback of information routinely provided

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Dimension 4: Delivery System Design

4.1 Patient assessment for self-management Value Specification Is the project defining this Is the project verifying this value? value? (Document source, (Document source, reference) reference) Value(s) Attribute(s) 4.1.1 Identifying Comprehensive Needs, Assessment of Cases Attitudes and Self-mgmt. Skills (service) Together with Patient

4.2 Structured therapeutic education Value Specification Is the project defining this value? Is the project (Document source, reference) verifying this value? (Document source, reference) Value(s) Attribute(s) 4.2.1 Providing Covering all aspects Therapeutic of Chronic Condition Education Providing Therapeutic Education (service) Through structured programmes

4.2.2 Various types Provided according of therapeutic to needs and education (service) preferences (individual appointments, online courses, etc.)

4.3 Psycho-social development of patients and mutual support Value Specification Is the project defining this value? Is the project (Document source, reference) verifying this value? (Document source, reference) Value(s) Attribute(s) 4.3.1 Increasing Problem Solving Confidence and Decision Making Motivation for self- Proper Use of HC care ability and SC resources (service). 4.3.2 Emotional By Patient and support is provided Caregiver support (service). group 361

4.4 Tools to facilitate self-management Value Specification Is the project defining this value? Is the project (Document source, reference) verifying this value? (Document source, reference) Value(s) Attribute(s) 4.4.4 Fostering Through Group Personal Activities Autonomy and Health (service) System Specification Is the project defining this System Is the project Specification? verifying this System Specification? SS 4.4.1: patients have clear, useful written information regarding their personal care plan (usability). SS 4.4.2: patients have secure electronic access to “personal health folders”, a part of their medical record that contains comprehensive information related to their condition (diagnosis, treatment, lifestyle recommendations, etc.). (functional). SS 4.4.3: self-management tools (telephone contact, remote monitoring, patient notes, alerts, devices for measuring biological parameters, pill boxes, etc.) are used as appropriate for each patient. (usability).

4.5 Shared decision-making Value Specification Is the project defining this value? Is the project (Document source, reference) verifying this value? (Document source, reference) Value(s) Attribute(s) 4.5.1 Patients are Clear, detailed, well informed relevant information (service). about health problems and options 4.5.2 Patient are In defining problems involved (service). and action plans

Negotiate priorities and objectives and evaluating progress

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Dimension 5: Decision Support

5.1 Protocols and shared guidelines Value Specification Is the project defining this value? Is the project (Document source, reference) verifying this value? (Document source, reference) Value(s) Attribute(s) 5.1.1 Clinical Covering Various Practice Guideline Care Settings and (service). Sources of Knowledge Used and Updated

5.1.3 Guidelines Covers most Protocols and comorbidities Expert Tools (service). System Specification Is the project defining this System Is the project Specification? verifying this System Specification? SS 5.1.2: algorithms for alerts and decision making, e.g., diagnosis and point-of-care clinical decision support related to therapeutic interventions, based on clinical practice guidelines, are included in patient medical records (functional).

5.2 Continued education and training Value Specification Is the project defining this Is the project verifying this value? value? (Document source, reference) (Document source, reference) Value(s) Attribute(s) 5.2.1 Evaluation on the of Training Management of Programmes Patients and (organizational) Conditions

5.3 Liaison and consultation Value Specification Is the project defining this value? Is the project (Document source, reference) verifying this value? (Document source, reference) Value(s) Attribute(s) 5.3.1 Face-to-face Clinical Sessions, Interaction among Consultations professionals between (service). professionals, rotations, etc. used for exchange of knowledge and expertise System Specification Is the project defining this System Is the project Specification? verifying this System

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Specification? SS 5.3.2: remote interaction (electronic referral of patients, referrals via e-mail, referral via on-line platforms) is used for the exchange of knowledge and expertise (usability).

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Dimension 6: Clinical Information Systems

6.1 Information for management and clinical practice Value Specification Is the project defining this value? Is the project (Document source, reference) verifying this value? (Document source, reference) Value(s) Attribute(s) 6.1.3 Clinical Assessing Indicators are multidimensional established aspects of chronic (service) condition

Prevalence Level of Diagnosis Level of Control Suitability of Treatment and Adherence Use of Hospitalization and Emergency Services System Specification Is the project defining this System Is the project Specification? verifying this System Specification? SS 6.1.1: the risk classification of patients in terms of their expected care requirements is included in their health record (functional). SS 6.1.2: patient lists can be compiled and activities planned by health problem, risk level or other relevant clinical parameters (functional). SS 6.1.4: processed data on indicators are provided to clinicians and managers on a regular basis to improve practice and management (service and functional). SS 6.1.5: the medical record is designed to be user-friendly and ergonomic in order to facilitate clinical monitoring by professionals (usability)

6.2 Integration of patient clinical data System Specification Is the project defining this System Is the project Specification? verifying this System Specification? SS 6.2.1: the electronic health record can be accessed and updated by all care areas (organizational and functional). SS 6.2.2: systems are in place to ensure the unequivocal identification of patients (functional). SS 6.2.3: patients can enter clinical information (symptoms, adherence, data from occupational health check-ups or private healthcare, etc.) in their personal

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health folders within their health record (functional). SS 6.2.4: information generated in other sectors (social services, public health) is shared between professionals (usability).

6.3 Reporting of clinical information between professionals. System Specification Is the project defining this System Is the project Specification? verifying this System Specification? SS 6.3.1: an e-referral or online consultation between professionals from different healthcare areas with electronic exchange of information is in place (organizational and functional). SS 6.3.2: a channel (direct phone line, mobile or other means of contact) is in place for consultations between professionals in real time across the various levels of care (service and functional).

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Raw Results.

Table 44 - Evaluation of Behaviours

LEADERS DOMAIN Scientifi Healthcar Busines Definition Desig Developmen c e s n t The coordination team developed an explicit vision of Chronic Care. Was the behaviour adopted? 2 3 0 3 3 3 Was the leader triggered to 3 3 2 3 3 3 perform this action at least in one of the following ways (conversation, notification, stands)? Was the decision linked to 3 3 1 2 2 3 project meetings, event or workshop? Was the decision stimulated 3 3 2 2 2 3 through a specific activity or tool developed during the project? Was the decision unpopular for 2 3 0 1 1 2 some group of people involved in the project? Was the decision interrupting an 3 2 2 3 0 1 existing routine (e.g. breaking an old habit) Was the decision properly 2 3 1 3 2 3 communicated, made understandable as an important thing to do? The coordination team: allocated resources to drive transformation of Diabetes Care with the aim of improving care for diabetic patients.

Was the behaviour adopted? 2 3 0 3 3 3 Was the leader triggered to 2 3 1 2 3 3 perform this action at least in one of the following ways (conversation, notification, stands)? Was the decision linked to 2 3 2 3 2 3 project meetings, event or workshop? Was the decision stimulated 2 3 2 2 2 3 through a specific activity or tool developed during the project? Was the decision unpopular for 2 2 0 1 2 0 some group of people involved in the project? Was the decision interrupting an 2 2 0 3 0 0 existing routine (e.g. breaking an old habit) Was the decision properly 2 2 2 3 2 3 communicated, made understandable as an important thing to do? Senior leaders of the Clinical partners promoted clinical leadership among members of multidisciplinary teams.

Was the behaviour adopted? 1 2 2 1

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Was the leader triggered to 2 3 2 1 perform this action at least in one of the following ways (conversation, notification, stands)? Was the decision linked to 1 2 2 1 project meetings, event or workshop? Was the decision stimulated 1 3 2 1 through a specific activity or tool developed during the project? Was the decision unpopular for 1 1 2 2 some group of people involved in the project? Was the decision interrupting an 1 2 1 3 existing routine (e.g. breaking an old habit) Was the decision properly 1 2 3 1 communicated, made understandable as an important thing to do?

Table 45 - Evaluation of Behaviours of the HC team

Members of the Health Care Team DOMAIN Healthcare Business Innovation with the participation of all stakeholders is encouraged. Was the behaviour adopted? 3 1 Were the members triggered to perform this action at least in one of the 3 2 following ways (conversation, notification, stands)? Were organization and turnovers implemented or periodic and scheduled 3 1 meeting organized in order to achieve the behaviour? Were members educated about this behaviour and made aware of this 3 2 situation? Were objectives, milestones or goals defined and shared around this 3 2 behaviour? Was the behaviour promoted enough? 3 2 Institutions, community agents, local bodies and the public work together with health institutions in planning community healthcare policies. Was the behaviour adopted? 3 Were the members triggered to perform this action at least in one of the 2 following ways (conversation, notification, stands)? Were organization and turnovers implemented or periodic and scheduled 2 meeting organized in order to achieve the behaviour? Were members educated about this behaviour and made aware of this 2 situation? Were objectives, milestones or goals defined and shared around this 2 behaviour? Was the behaviour promoted enough? 2 Formal and informal relationships between professionals with joint activities in different healthcare levels are encouraged. Was the behaviour adopted? 3 Were the members triggered to perform this action at least in one of the 3 following ways (conversation, notification, stands)? Were organization and turnovers implemented or periodic and scheduled 3 meeting organized in order to achieve the behaviour?

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Were members educated about this behaviour and made aware of this 3 situation? Were objectives, milestones or goals defined and shared around this 3 behaviour? Was the behaviour promoted enough? 3

Table 46 - Evaluation of the patients' behaviour

PATIENTS DOMAIN Healthcare Definition Design Development

The participation of patients and caregivers in associations, working groups, social networks and patient forums is encouraged.

Was the behaviour adopted? 1 3 2 2 Were the members triggered to 1 3 3 1 perform this action at least in one of the following ways? 1) Notifications 2) Stands (e.g.: 3) Conversations It may, in that case it is advisable to 1 2 2 2 integrate it as part of a new or a bigger routine. The fear of failing could be a problem, 1 3 1 2 as the lack of hope, so one should avoid this kind of situations. In this case, stepwise milestones and goals could help.

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Table 47 - Implementation of Healthcare Systems related Dimensions (1 and 2)

CCM Dimension Scientific Business Healthcare 1 From WP Out of From WP Out of the From WP Out of the the the project the the project project project project project Strategic Framework 1.2.1 Strategic 2 4 1 2 7 Approach to CC in Place (organizational) 1.2.2 2 4 2 6 Measurable Objectives (organizational) Population Approach 1.3.1.1 Care 3 3 2 4 2 Model geared to improve health (organizational) 1.3.1.2 Care 3 3 0 0 2 Model geared to reduce inequalities (organizational) Information system for evaluation, improvement and innovation 1.4.2 1 4 0 0 2 Measurements of Quality, Health Outcomes and Efficiency (organizational) 1.4.3.1 2 4 1 4 2 Collaborative Learning methods (service) 1.4.3.2 Good 3 4 1 4 3 Practice methods (service) Funding Scheme 1.5.1 Funding 0 0 2 8 Scheme rolled out (organizational) 1.5.2 Improved 3 7 1 7 Quality of Chronic Healthcare (organizational) Social and HC Policies 1.6.1.1 Policies 2 7 2 7 1 to Promote Coordination of SC and HC (organizational) 1.6.1.2 Policies 2 7 2 7 1 to Promote Integration of SC and HC (organizational) CCM Dimension Scientific Business Healthcare 2 From the WP Out of the From the WP Out of From the WP Out of the project project project the project project 370

project Community Strategies in Health Plans 2.1.1 Designing 0 0 2 4 3 Programmes and Community Projects Reflecting Community Needs(service) Alliances with Community Stakeholders 2.2.1 Designing 3 8 1 8 1 Programmes and Community Projects through agreements (organizational) 2.2.2 Partnership 2 8 2 8 2 and Cooperation (organizational) 2.3.1 Meeting the 2 0 0 3 needs of Chronic Patients (service)

Table 48 - Implementation of Healthcare Systems related Dimensions (3, 4 and 5), as rated by the Healthcare Manager

CCM Dimension 3

From the WP Out of the project project 3.1 Patient Centred Care 3.1.1 HC contact Person (service) 3 3.1.4 Keeping patients in their environments (service) 3 3.2 Professional Competences Related to Chronic Care. 3.2.1 Management of Chronic Patients (service) 3 3.2.2 Coordination and Continuity of Care 3

3.2.3 Management of high-risk chronic patients. (service) 2 3.2.4 Emotional Support (service) 2 3.3 Multidisciplinary teamwork 3.3.3.1 Improved Planning (organizational) 1 3.3.3.2 Improved Implementation (organizational) 1 3.3.3.3 Improvement of Care Models (organizational) 2 3.3.4 Shared Goals (service) 1 3.4 Integration and Continuity of Care 3.4.1 Pathways between Primary and Secondary Care 2 (service) 3.4.2 Defining and Applying Care Processes (service) 3 3.4.3 Integrated and multidisciplinary care process (service) 2 3.4.5 Alternative Routes for poor control or worsening 3 (service) 3.5 Active Patient Follow-up. 3.5.1 Standardised and Personalized Plans of Action 3 (service)

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3.5.4 Detect and Address Efficacy, Safety and Adherence 2 (service) 3.6 Innovation in interactions between patients and healthcare professionals. 3.6.5 Group Sessions (service) 1 3.7 Clinical management of chronic conditions and incentive schemes. 3.7.1 Teams are Independent (organizational) 1 3.7.2 Incentive Schemes for Professionals (organizational) 2 3.7.3 Improve Practice (service) 3 CCM Dimension 4

4.1 Patient assessment for self-management 4.1.1 Identifying Needs, Attitudes and Self-mgmt. Skills 3 (service) 4.2 Structured therapeutic education 4.2.1 Providing Therapeutic Education 3 4.2.2 Various types of therapeutic education (service) 3 4.3 Psycho-social development of patients and mutual support 4.3.1 Increasing Confidence and Motivation for self-care 3 ability (service). 4.3.2 Emotional support is provided (service). 1 4.4 Tools to facilitate self-management 4.4.4 Fostering Personal Autonomy and Health (service) 3 4.5 Shared decision-making 4.5.1 Patients are well informed (service). 3 4.5.2 Patient are involved (service). 3 CCM Dimension 5

5.1 Protocols and shared guidelines 5.1.1 Clinical Practice Guideline (service). 2 5.1.3 Guidelines Protocols and Expert Tools (service). 2 5.2 Continued education and training 5.2.1 Evaluation of Training Programmes (organizational) 2 5.3 Liaison and consultation 5.3.1 Face-to-face Interaction among professionals 1 (service).

Table 49 - Implementation of System Specifications (Dimensions 3, 4, 5 and 6), rated by the Implementation Team (Definition, Design, Development)

CCM Dimension 3 Definition Design Development

From WP From the WP From the WP the project project projec t 3.1 Patient-centred care SS 3.1.2 Patients have a contact number to 3 4 3 4 1 1.4 obtain a device from a healthcare professional on a 24-hour basis (other than emergency services). (functional) Integration and Continuity of Care

372

SS 3.4.4: alert systems are in place for 3 2 3 2 2 3 informing and activating the clinical team during referral processes and transitions of care (hospital admission and discharge). (service) 3.5 Active Patient Follow-up. SS 3.5.2: a comprehensive care plan for each 3 1 3 1 3 1.5 patient, with objectives for prevention, clinical control and symptoms control and self- management, is recorded in his/her medical record. (functional) SS 3.5.3: alerts have been set up in the 3 1 3 1 3 1.5 information system to make professionals aware that a patient’s condition has become poorly controlled. (functional) 3.6 Innovation in interactions between patients and healthcare professionals. SS 3.6.1: technology is used to allow remote 3 1 3 1 3 1 interaction between patients and professionals (usability). SS 3.6.2: telemonitoring or teleconsultation is 3 2 3 2 3 1 commonly used to monitor/follow-up patients (functional). SS 3.6.3: websites, social networks, and blogs 1 3 3 3 2 1.5 with health education content are promoted (service and usability). SS 3.6.4: structured and proactive 2 2 3 2 2 3 programmes are in place for remote monitoring/follow-up of chronic patients (functional).

CCM Dimension 4 Definition Design Development

From WP From the WP From the WP the project project projec t 4.4 Tools to facilitate self-management SS 4.4.1: patients have clear, useful written 3 3 3 3 3 1 information regarding their personal care plan (usability). SS 4.4.2: patients have secure electronic 3 1 2 1 3 4 access to “personal health folders”, a part of their medical record that contains comprehensive information related to their condition (diagnosis, treatment, lifestyle recommendations, etc.). (functional). SS 4.4.3: self-management tools (telephone 3 1 3 1 3 1 contact, remote monitoring, patient notes, alerts, devices for measuring biological parameters, pill boxes, etc.) are used as appropriate for each patient. (usability).

CCM Dimension 5 Definition Design Development

From WP From the WP From the WP the project project projec t 5.1 Protocols and shared guidelines

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SS 5.1.2: algorithms for alerts and decision 3 1 3 1 2 1 making, e.g., diagnosis and point-of-care clinical decision support related to therapeutic interventions, based on clinical practice guidelines, are included in patient medical records (functional). 5.3 Liaison and consultation SS 5.3.2: remote interaction (electronic 1 4 3 4 0 3 referral of patients, referrals via e-mail, referral via on-line platforms) is used for the exchange of knowledge and expertise (usability).

CCM Dimension 6 Definition Design Development

From WP From the WP From the WP the project project projec t 6.1 Information for management and clinical practice SS 6.1.1: the risk classification of patients in 3 1 2 1 1 3 terms of their expected care requirements is included in their health record (functional). SS 6.1.2: patient lists can be compiled and 3 1 2 1 2 3 activities planned by health problem, risk level or other relevant clinical parameters (functional). SS 6.1.4: processed data on indicators are 2 3 3 3 3 3 provided to clinicians and managers on a regular basis to improve practice and management (service and functional). SS 6.1.5: the medical record is designed to be 3 3 3 3 3 3 user-friendly and ergonomic in order to facilitate clinical monitoring by professionals (usability) 6.2 Integration of patient clinical data SS 6.2.1: the electronic health record can be 3 1 3 1 1 3 accessed and updated by all care areas (organizational and functional). SS 6.2.2: systems are in place to ensure the 3 1 3 1 3 3 unequivocal identification of patients (functional). SS 6.2.3: patients can enter clinical 3 1 3 1 3 1 information (symptoms, adherence, data from occupational health check-ups or private healthcare, etc.) in their personal health folders within their health record (functional). SS 6.2.4: information generated in other 2 4 3 4 0 3 sectors (social services, public health) is shared between professionals (usability). 6.3 Reporting of clinical information between professionals. SS 6.3.1: an e-referral or online consultation 1 4 3 4 0 3 between professionals from different healthcare areas with electronic exchange of information is in place (organizational and functional). SS 6.3.2: a channel (direct phone line, mobile 2 4 2 4 0 3 or other means of contact) is in place for consultations between professionals in real time across the various levels of care (service and functional).

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